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In wake of baby formula crisis, critical report recommends major food safety changes at FDA

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CNN
 — 

To help prevent outbreaks of food-related illness and problems like the formula shortage that left many parents in the US without adequate access to food for their babies, the US Food and Drug Administration needs a clearer mission and a different kind of leadership, and it has to act with more urgency, according to a highly critical new report.

After the agency faced serious criticism for its handling of the formula shortage, FDA Commissioner Dr. Robert Califf commissioned the review of the Human Foods Program in July from the Reagan-Udall Foundation, an independent group of experts.

The need for a review was considered so urgent that Califf asked the group to submit the report in 60 business days – lightning speed for government-focused reports. It was submitted to the FDA on Tuesday.

About 48 million Americans get some kind of foodborne illness every year, according to the US Centers for Disease Control and Prevention. Of those, 128,000 are hospitalized, and 3,000 die. Produce alone in 2019 was responsible for 46% of foodborne illness outbreaks, according to the US Department of Agriculture.

The FDA oversees the safety of 78% of the US human food supply.

It enforces food safety regulations, works with local governments on food safety information, promotes dietary guidelines, and develops food safety information and education, as well as overseeing nutrition labels on most food and being responsible for promoting good nutrition practices to the US public.

The US food supply is generally recognized as safe, the Reagan-Udall Foundation’s report said, but the FDA needs to be much more proactive in dealing with foodborne pathogens in order to protect Americans.

“An approach that is primarily focused on identifying and reacting to acute outbreaks of foodborne illness and death is unacceptable,” the report says.

Americans’ nutrition can also improve, the report says. Most people don’t follow the US dietary recommendations, and more than a million die of diseases that can be linked to diet such as heart disease, type 2 diabetes and cancer each year, according to the FDA

“Relying solely on food labeling and consumer education to drive the needed changes in the food supply is also an unacceptable strategy for reducing diet-related chronic diseases,” the new report says.

The report suggests that the agency needs major reform in order to do a better job managing food in the US. Some of the proposed changes would require congressional approval.

The report has several suggestions for ways to reach these goals. One would create a separate Center for Nutrition within the US Department of Health and Human Services. Another would have the FDA develop a strategy to increase funding for the Human Foods Program, with help from Congress. The agency could also connect its technology systems so they better communicate with each other.

The FDA could seek to amend the Federal Food, Drug, and Cosmetic Act to allow the disclosure of more information to local agencies. Or it could get regulatory authority to request records from food manufacturers in advance or in lieu of inspection.

The report recommends that the FDA explore applying its authority to require infant formula manufacturers, for instance, to keep microbiological testing records that are available on request so there is real-time disclosure of results.

It also suggests that the FDA use its mandatory recall authority more often and that there should be a process by which accommodations are made for products that are considered life-sustaining, like formula. At the moment, food recalls are usually voluntarily initiated by a manufacturer or food distributor.

The report also notes that the food program is run under the leadership of several managers. This “lack of a single, clearly identified person” to lead the program has led to a culture of “constant turmoil” and “indecisiveness and inaction” that has created “disincentives for collaboration,” according to the report.

That turmoil was partly to blame for the agency’s problematic handling of the formula shortage, the report says.

Experts have said the agency failed to act quickly enough on sanitation complaints at an Abbott Nutrition formula manufacturing facility in Michigan, and because of a lack of communication across departments, it didn’t circumvent what became a massive shortage of formula after the plant shut down.

“A review of events indicates that lack of communication and engagement across the Agency accounted, in part, for missteps,” the new report says. “There was little motivation, and apparently no requirement, to share information and interact across the Agency to facilitate critical thinking and proactive decision-making.

“This is especially problematic in a crisis, where decisions should be made quickly and be vetted properly.”

The report suggests that the FDA create a new structure with clear roles and leaders. It also encourages development of a culture that is more transparent, that acts quickly and collaborates.

“The current culture of the FDA Human Foods Program is inhibiting its ability to effectively accomplish this goal” of protecting public health,” the report says.

Califf said Tuesday that the agency has not had the opportunity to review the report in depth but that the report provides “significant observations” and options to consider.

“The work of these independent evaluators will help to inform a new vision for the FDA Human Foods Program,” Califf said in a news release.

Some critics have suggested that food safety takes a back seat to the FDA’s regulations of drugs and medical devices. Califf acknowledged that food policy was important to the agency, citing the decline in life expectancy in the US largely due to chronic diseases that can be improved with good nutrition.

“The Human Foods Program is a top priority for the agency. America’s food supply is as safe as it’s ever been,” he said. “That said, over the past several years, the program has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain, the ongoing impacts associated with climate change and rapid advances in the science underlying many of the foods we eat today.”

The FDA will inform the public about how it is moving forward on the panel’s suggestions by the end of January and will provide additional updates at the end of February, including on any structural or procedural changes it will make, Califf said.

He said he’s putting together a group of leaders at the FDA that will advise him on how to “operationalize these findings,” and he expects these leaders to be “bold and focused on the transformative opportunities ahead for the FDA’s food program.”

In April, a coalition of 30 organizations that represent industry, local regulators and consumers sent a letter to the FDA asking for the creation of a deputy commissioner for foods with direct line authority over all the agency’s food components.

One of the organizations, Consumer Reports, has called for months for more accountability and focused leadership from the FDA.

“We need strengthened leadership and accountability at the FDA to implement a culture of prevention, respond more quickly to problems as they arise, and take timely action on proposed food safety rules and initiatives,” Brian Ronholm, Consumer Reports’ director of food policy, said Tuesday.

Ronholm called the new report a “very encouraging first step.”

“We cannot afford to tolerate the status quo and let this moment go by without adopting fundamental changes to improve the FDA’s ability to protect the public and ensure our food is safe,” he said in a statement.

The Consumer Brands Association, a trade association for food manufacturers that also signed the April letter, said Tuesday that the lack of a single leader on food policy leads to “a lot of inefficiencies.”

“A siloed approach across FDA makes it harder for industry to engage,” said Sarah Gallo, the organization’s vice president for product policy. “It is just really complicated when you don’t have somebody looking over the different parts of the agency that have some form of jurisdiction over all those things.

“We can’t ignore what happened with the formula crisis,” Gallo added, a tangible example of what can happen when the FDA is not functioning at its best.

Roberta Wagner, vice president of regulatory and technical affairs for the Consumer Brands Association, agreed that if there were one person in charge, they could make sure the inspection and policy parts of the FDA would work together.

Wagner added that the food industry has embraced a more prevention-oriented kind of philosophy when it comes to safety. “Quite frankly, the problem is, FDA’s inspection force has not modernized itself or its approaches to basically mirror that prevention-oriented system and philosophy,” Wagner said.

The FDA food division has its work cut out for it, though, added Wagner, who worked with the agency in several capacities before joining the association.

“Think about it: The FDA has to keep up with hundreds of thousands of farms and facilities,” she said. “If you have these siloed operations, you’re not having these really critical conversations about where we should be and what should we be doing out there.

“We all want an FDA with a strong foods program. We want consumers not to worry about what they’re eating or whether they’re going to be able to get that certain needed food product,” Wagner added.

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Health

Ultraprocessed food may contribute to dementia, study says

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CNN
 — 

We all eat them — ultraprocessed foods such as frozen pizza and ready-to-eat meals make our busy lives much easier. Besides, they are just darn tasty — who isn’t susceptible to hot dogs, sausages, burgers, french fries, sodas, cookies, cakes, candy, doughnuts and ice cream, to name just a few?

If more than 20% of your daily calorie intake is ultraprocessed foods, however, you may be raising your risk for cognitive decline, a new study found.

That amount would equal about 400 calories a day in a 2,000-calories-a-day diet. For comparison, a small order of fries and regular cheeseburger from McDonald’s contains a total of 530 calories.

The part of the brain involved in executive functioning — the ability to process information and make decisions — is especially hard hit, according to the study published Monday in JAMA Neurology.

Men and women in the study who ate the most ultraprocessed foods had a 25% faster rate of executive function decline and a 28% faster rate of overall cognitive impairment compared with those who ate the least amount of overly processed food.

“While this is a study of association, not designed to prove cause and effect, there are a number or elements to fortify the proposition that some acceleration in cognitive decay may be attributed to ultraprocessed foods,” said Dr. David Katz, a specialist in preventive and lifestyle medicine and nutrition, who was not involved in the study.

“The sample size is substantial, and the follow-up extensive. While short of proof, this is robust enough that we should conclude ultraprocessed foods are probably bad for our brains.”

There was an interesting twist, however. If the quality of the overall diet was high — meaning the person also ate a lot of unprocessed, whole fruits and veggies, whole grains and healthy sources of protein — the association between ultraprocessed foods and cognitive decline disappeared, Katz said.

“Ultraprocessed foods drag diet quality down, and thus their concentration in the diet is an indicator of poor diet quality in most cases,” Katz said. “Atypical as it seems, apparently some of the participants managed it. And when diet quality was high, the observed association between ultraprocessed foods and brain function abated.”

The study followed over 10,000 Brazilians for up to 10 years. Just over half of the study participants were women, White or college educated, while the average age was 51.

Cognitive testing, which included immediate and delayed word recall, word recognition and verbal fluency, was performed at the beginning and end of the study, and participants were asked about their diet.

“In Brazil, ultraprocessed foods make up 25% to 30% of total calorie intake. We have McDonald’s, Burger King, and we eat a lot of chocolate and white bread. It’s not very different, unfortunately, from many other Western countries,” coauthor Dr. Claudia Suemoto, an assistant professor in the division of geriatrics at the University of São Paulo Medical School, told CNN when the study abstract was released in August.

“Fifty-eight percent of the calories consumed by United States citizens, 56.8% of the calories consumed by British citizens, and 48% of the calories consumed by Canadians come from ultraprocessed foods,” Suemoto said.

Ultraprocessed foods are defined as “industrial formulations of food substances (oils, fats, sugars, starch, and protein isolates) that contain little or no whole foods and typically include flavorings, colorings, emulsifiers, and other cosmetic additives,” according to the study.

Those in the study who ate the most ultraprocessed foods were “more likely to be younger, women, White, had higher education and income, and were more likely to have never smoked, and less likely to be current alcohol consumers,” the study found.

In addition to the impact on cognition, ultraprocessed foods are already known to raise the risk of obesity, heart and circulation problems, diabetes, cancer and a shorter life span.

“Ultraprocessed foods in general are bad for every part of us,” said Katz, president and founder of the nonprofit True Health Initiative, a global coalition of experts dedicated to evidence-based lifestyle medicine.

Ultaprocessed foods are usually high in sugar, salt and fat, all of which promote inflammation throughout the body, which is “perhaps the most major threat to healthy aging in the body and brain,” said Dr. Rudy Tanzi, professor of neurology at Harvard Medical School and director of the genetics and aging research unit at Massachusetts General Hospital in Boston. He was not involved in the study.

“Meanwhile, since they are convenient as a quick meal, they also replace eating food that is high in plant fiber that is important for maintaining the health and balance of the trillions of bacteria in your gut microbiome,” Tanzi added, “which is particularly important for brain health and reducing risk of age-related brain diseases like Alzheimer’s disease.”

How can you keep this from happening to you? If you include ultraprocessed foods in your diet, try to counter these by also eating high-quality, whole foods such as fruits, vegetables and whole grains.

“The conclusion suggested here is that ultraprocessed foods are, indeed, an important ‘ingredient,’ but the exposure that should be the focus of public health efforts is overall diet quality,” Katz said.

One easy way to ensure diet quality is to cook and prepare your food from scratch, Suemoto said.

“We say we don’t have time, but it really doesn’t take that much time,” Suemoto said.

“And it’s worth it because you’re going to protect your heart and guard your brain from dementia or Alzheimer’s disease. That’s the take-home message: Stop buying things that are superprocessed.”

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Health

Improve memory as you age by eating more flavonols, study says

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CNN
 — 

Eating more flavonols, antioxidants found in many vegetables, fruits, tea and wine, may slow your rate of memory loss, a new study finds.

The cognitive score of people in the study who ate the most flavonols declined 0.4 units per decade more slowly than those who ate the fewest flavonols. The results held even after adjusting for other factors that can affect memory, such as age, sex and smoking, according to the study recently published in Neurology, the medical journal of the American Academy of Neurology.

“It’s exciting that our study shows making specific diet choices may lead to a slower rate of cognitive decline,” said study author Dr. Thomas Holland, an instructor in the department of internal medicine at Rush University Medical Center in Chicago, in a statement.

“Something as simple as eating more fruits and vegetables and drinking more tea is an easy way for people to take an active role in maintaining their brain health.”

Flavonols are cytoprotective, meaning they protect cells, including neurons, so it’s plausible there could be a direct impact on cognition, said Dr. David Katz, a specialist in preventive and lifestyle medicine and nutrition who was not involved in the study.

“But they are also a marker of higher intake of fruits and vegetables — which is good for the brain because it is good for every vital organ, and the organism as a whole,” Katz said in an email.

“They may also be a marker of better overall diet quality, or even greater health consciousness. People who are more health conscious may do things to preserve their cognition, or maybe being more health conscious is a by-product of better cognition.”

Plants contain over 5,000 flavonoid compounds, which play roles in producing cell growth, fighting environmental stress and attracting insects for pollination.

Flavonols, a type of flavonoid, have been shown in animal and some human studies to reduce inflammation, a major trigger for chronic disease, and are rich sources of antioxidants. Antioxidants combat free radicals, “highly unstable molecules that are naturally formed when you exercise and when your body converts food into energy,” according to the National Center for Complementary and Integrative Health, part of the National Institutes of Health.

One of the most common flavonols, quercetin, has shown promise in reducing the onset of colorectal cancer and other cancers, according to studies. Onions contain the highest levels — lower levels can be found in broccoli, blueberries, cauliflower, curly kale, leeks, spinach and strawberries.

Another common flavonol, kaempferol, appears to inhibit the growth of cancer cells while preserving and protecting normal cells. Good sources of kaempferol are onions, asparagus and berries, but the richest plant sources are spinach, kale and other green leafy vegetables, as well as herbs such as chives, dill and tarragon.

A third major player is myricetin, which has been studied in rodents for blood sugar control and the reduction of tau, a protein that causes the hallmark tangles of Alzheimer’s and other dementia. Spinach and strawberries contain high levels of myricetin, but honey, black currants, grapes and other fruits, berries, vegetables, nuts and tea are also good sources.

The last group of flavonols, isorhamnetin, may protect against cardiovascular and neurovascular disease in addition to anti-tumor and anti-inflammatory benefits. Good sources of isorhamnetin are pears, olive oil, wine and tomato sauce.

You can find a full list of the flavonoid content of various fruits and vegetables here.

The new study asked 961 people with an average age of 81 and no signs of dementia to fill out a food questionnaire each year for seven years. In addition, the participants underwent annual cognitive and memory tests and were quizzed on their time spent being physically and mentally active.

People were divided into groups based on their daily intake of flavonols. The lowest intake was about 5 milligrams a day; the highest 15 milligrams a day — equal to about a cup of dark leafy greens, the study noted. (For comparison, the average flavonol intake in US adults is about 16 to 20 milligrams per day, according to the study.)

The study looked at the impact of the four major flavonols — kaempferol, quercetin, myricetin and isorhamnetin — on the rate of cognitive decline over the seven years.

The greatest impact was found with kaempferol: People who ate the highest amounts of foods with kaempferol showed a 0.4 units per decade slower rate of cognitive decline compared with those who ate the fewest, according to the study.

Myricetin was next: People who ate the most foods with myricetin had a 0.3 units per decade slower rate of cognitive decline compared with the lowest consuming group. People who ate the most foods with quercetin showed a 0.2 units per decade slower rate of cognitive decline.

Dietary isorhamnetin had no impact, the study found.

Despite the apparent positives, studies on the impact of flavonols on human health have been inconclusive -— mainly because many are observational and cannot show a direct cause and effect. That applies to the Neurology study as well, according to its authors.

A few randomized controlled trials — the scientific gold standard — have shown benefits associated with flavonols for controlling blood sugar in type 2 diabetes and improving cardiovascular health, according to the Linus Pauling Institute, home to the Micronutrient Information Center, an online database for nutrition information.

It’s not known whether these benefits are long term, the institute said, and no clear impact has been shown for cancer prevention or cognitive protection.

“There are other bioactives that may contribute to the observed outcomes,” Katz said. “Supplemental studies are required to isolate flavonoid effects fully.”

There’s also a downside to assuming a health impact without the necessary studies to back it up, said Dr. Christopher Gardner, a research professor of medicine and director of the Nutrition Studies Research Group at Stanford University.

“You can count on Americans wanting the benefits of plants but not wanting to eat them,” he said in an email.

“(What) if people read the headline and rush out and buy bottled (extracted) flavonols instead of eating whole plant foods, and it turns out it wasn’t just the flavonols, but the package deal of everything in those plants (instead).”

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Science

SpaceX launches tomato seeds, other supplies to space station

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CNN
 — 

SpaceX is carrying a fresh haul of supplies to the International Space Station this weekend after bad weather at the launch site forced the company to wave off its first attempt.

The mission took off from NASA’s Kennedy Space Center in Florida around 2:20 p.m. ET Saturday. The original liftoff date had been Tuesday.

The bounty of supplies on board includes a pair of new solar arrays for the space station, dwarf tomato seeds and a range of science experiments. There will also be treats for the astronauts on the space station, like ice cream and Thanksgiving fare like spicy green beans, cranberry apple desserts, pumpkin pie and candy corn.

The solar arrays will be installed outside the floating laboratory during spacewalks scheduled for November 29 and December 3. They will give the space station a power boost.

SpaceX has launched more than two dozen resupply missions to the space station over the past decade as part of a multibillion-dollar deal with NASA. This launch comes amid SpaceX’s busiest year to date, with more than 50 operations so far, including two astronaut missions.

The cargo on board includes a number of health-related items, such as the Moon Microscope kit. The portable handheld microscope will allow astronauts to collect and send images of blood samples to flight surgeons on the ground for diagnostics and treatment.

Nutrients are a key component of maintaining good health in space. But fresh produce is in short supply on the space station compared with the prepackaged meals astronauts eat during their six-month stays in low-Earth orbit.

“It is fairly important to our exploration goals at NASA to be able to sustain the crew with not only nutrition but also to look at various types of plants as sources for nutrients that we would be hard-pressed to sustain on the long trips between distant destinations like Mars and so forth,” said Kirt Costello, chief scientist at NASA’s International Space Station Program and a deputy manager of the ISS Research Integration Office.

Astronauts have grown and tasted different types of lettuce, radishes and chiles on the International Space Station. Now, the crew members can add some dwarf tomatoes — specifically, Red Robin tomatoes — to their list of space-grown salad ingredients.

The experiment is part of an effort to provide continuous fresh food production in space.

The dwarf tomato seeds will be grown under two different light treatments to measure the impact on the number of tomatoes that can be harvested as well as the plants’ nutritional value and taste. Red Robin tomatoes will also be grown on Earth as a control experiment. The two crops will be compared to measure the effects of a zero-gravity environment on tomato growth.

The space tomatoes will be grown inside small bags called plant pillows installed in the Vegetable Production System, known as the Veggie growth chamber, on the space station. The astronauts will frequently water and nurture the plants.

“Tomatoes will be a new adventure for us on the veggie team, trying to figure out how to keep these thirsty plants well watered without overwatering,” said Gioia Massa, NASA’s space crop production scientist and principal investigator for the tomato study.

The tomatoes will be ready for their first taste test in the spring.

The crew is expecting tomato harvests 90, 97 and 104 days after the plants begin to grow. During taste tests, the crew will rate the flavor, aroma, juiciness and texture of the tomatoes grown using the different light treatments. Half of each tomato harvest will be frozen and returned to Earth for analysis.

Growing plants on the space station not only provides the opportunity for fresh food and creative taco nights, it can also boost the mood of the crew during their long spaceflight.

Surveys will track astronauts’ moods as they care for and interact with the plants to see how nurturing the seedlings enhances the crew’s experience amid the isolation of the space station.

The hardware is still in development for larger crop production on the space station and eventually other planets, but scientists are already planning what plants might grow best on the moon and Mars. Earlier this year, a team successfully grew plants in lunar soil that included samples collected during the Apollo missions.

“Tomatoes are going to be a great crop for the moon,” Massa said. “They’re very nutritious, very delicious, and we think the astronauts will be really excited to grow them there.”

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Science

Dwarf tomato seeds will launch to ISS aboard SpaceX’s next resupply flight

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CNN
 — 

When SpaceX’s 26th commercial resupply mission launches Tuesday, it will carry a bounty of supplies, a pair of new solar arrays, dwarf tomato seeds and a range of science experiments to the International Space Station.

The mission will also deliver ice cream and Thanksgiving-style treats, including spicy green beans, cran-apple desserts, pumpkin pie and candy corn, to the space station crew.

The Dragon spacecraft is expected to lift off with its 7,700 pounds (3,493 kilograms) of cargo from NASA’s Kennedy Space Center at 3:54 p.m. ET, with live coverage available on NASA’s website beginning at 3:30 p.m. ET.

The International Space Station Roll Out Solar Arrays, or iROSAs, will be installed outside the floating laboratory during spacewalks scheduled for November 29 and December 3. The solar arrays will give the space station a power boost.

The cargo includes a number of health-related items, such as the Moon Microscope kit. The portable handheld microscope will allow astronauts to collect and send images of blood samples to flight surgeons on the ground for diagnostics and treatment.

Nutrients are a key component of maintaining good health in space. But fresh produce is in short supply on the space station compared with the prepackaged meals astronauts eat during their six-month stays in low-Earth orbit.

“It is fairly important to our exploration goals at NASA to be able to sustain the crew with not only nutrition but also to look at various types of plants as sources for nutrients that we would be hard pressed to sustain on the long trips between distant destinations like Mars and so forth,” said Kirt Costello, chief scientist at NASA’s International Space Station Program and a deputy manager of the ISS Research Integration Office.

Astronauts have grown and tasted different types of lettuce, radishes and chiles on the International Space Station. Now, the crew members can add some dwarf tomatoes — specifically, Red Robin tomatoes — to their list of space-grown salad ingredients.

The experiment, known as the Pick-and-Eat Salad-Crop Productivity, Nutritional Value, and Acceptability to Supplement the ISS Food System, is part of an effort to provide continuous fresh food production in space.

The dwarf tomato seeds will be grown under two different light treatments to measure their impact on how many tomatoes can be harvested, as well as the plants’ nutritional value and taste. Red Robin tomatoes will also be grown on Earth as a control experiment. The two crops will be compared to measure the effects of the zero gravity environment on tomato growth.

The space tomatoes will be grown inside small bags called plant pillows installed in the Vegetable Production System, known as the Veggie growth chamber, on the space station. The astronauts will frequently water and nurture the plants as they grow, as well as pollinate the flowers.

“Tomatoes will be a new adventure for us on the Veggie team, trying to figure out how to keep these thirsty plants well watered without over watering,” said Gioia Massa, NASA’s space crop production scientist and principal investigator for the tomato study.

The tomatoes will be ready for their first taste test in the spring.

The crew is expecting three tomato harvests 90, 97 and 104 days after the plants begin to grow. During taste tests, the crew will rate the flavor, aroma, juiciness and texture of the tomatoes grown using the two different light treatments. Half of each tomato harvest will be frozen and returned to Earth for analysis.

Growing plants on the space station not only provides the opportunity for fresh food and creative taco nights, it can also boost the mood of the crew during their long spaceflight.

The astronauts will also take surveys to track their moods as they care for and interact with the plants to see how nurturing the seedlings enhances their experience amid the isolation and confinement of the space station.

The hardware is still in development for larger crop production on the space station and eventually other planets, but scientists are already planning what plants might grow best on the moon and Mars. Earlier this year, a team successfully grew plants in lunar soil that included samples collected during the Apollo missions.

“Tomatoes are going to be a great crop for the moon,” Massa said. “They’re very nutritious, very delicious and we think the astronauts will be really excited to grow them there.”

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Health

Study suggests that HDL or ‘good’ cholesterol is less beneficial than previously thought, especially for Black adults

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CNN
 — 

High-density lipoprotein, or HDL, cholesterol – often referred to as the “good” cholesterol – may not be as useful in predicting the risk of heart disease and protecting against it as previously thought, according to new researched funded by the National Institutes of Health.

A study from the 1970s found that high levels of HDL cholesterol concentration were associated with low coronary heart disease risk, a link that has since been widely accepted and used in heart disease risk assessments. However, only White Americans were included in that study.

Now, research published Monday in the Journal of the American College of Cardiology found that low levels of HDL cholesterol were associated with higher risk of heart attack among White adults, but the same was not true among Black adults. Also, higher levels of HDL cholesterol were not found to reduce the risk of cardiovascular disease for either group.

“It’s been well accepted that low HDL cholesterol levels are detrimental, regardless of race. Our research tested those assumptions,” said Nathalie Pamir, a senior author of the study and an associate professor of medicine at the Knight Cardiovascular Institute at Oregon Health & Science University, Portland, in a news release. “It could mean that in the future, we don’t get a pat on the back by our doctors for having higher HDL cholesterol levels.”

The researchers used data from thousands of people who were enrolled in the Reasons for Geographic and Racial Differences in Stroke (REGARDS) cohort. Participants were at least 45 years old when they enrolled in the program between 2003 and 2007, and their health was analyzed over an average of 10 years.

The researchers found that high levels of low-density lipoprotein (LDL) cholesterol and triglycerides “modestly” predicted heart disease risk among both Black and White adults.

But they suggest that more work is needed to understand what’s driving the racial differences in the link between HDL and heart disease risk.

And in the meantime, current clinical assessments for heart disease risk “may misclassify risk in Black adults, potentially hindering optimal cardiovascular disease prevention and management programs for this group,” they wrote.

CNN Medical Correspondent Dr. Tara Narula, associate director of the Lenox Hill Women’s Heart Program, said the study “highlights the very important need for more race- and ethnic-specific research and that there is not a one-size-fits-all approach. Additionally, this research emphasizes the continued need to educate that high levels of HDL are not a free pass and focus must be placed on controlling elevated LDL and other known markers of increased cardiovascular risk. “

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Health

Don’t bother with dietary supplements for heart health, study says

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CNN
 — 

Six supplements that people commonly take for heart health don’t help lower “bad” cholesterol or improve cardiovascular health, according to a study published Sunday, but statins did.

Some people believe that common dietary supplements – fish oil, garlic, cinnamon, turmeric, plant sterols and red yeast rice – will lower their “bad” cholesterol. “Bad” cholesterol, known in the medical community as low-density lipoproteins or LDL, can cause the buildup of fatty deposits in the arteries. The fatty deposits can block the flow of oxygen and blood that the heart needs to work and the blockage can lead to a heart attack or stroke.

For this study, which was presented at the American Heart Association’s Scientific Sessions 2022 and simultaneously published in the Journal of the American College of Cardiology, researchers compared the impact of these particular supplements to the impact of a low dose of a statin – a cholesterol-lowering medication – or a placebo, which does nothing.

Researchers made this comparison in a randomized, single-blind clinical trial that involved 190 adults with no prior history of cardiovascular disease. Study participants were ages 40 to 75, and different groups got a low-dose statin called rosuvastatin, a placebo, fish oil, cinnamon, garlic, turmeric, plant sterols or red yeast rice for 28 days.

The statin had the greatest impact and significantly lowered LDL compared with the supplements and placebo.

The average LDL reduction after 28 days on a statin was nearly 40%. The statin also had the added benefit on total cholesterol, which dropped on average by 24%, and on blood triglycerides, which dropped 19%.

None of the people who took the supplements saw any significant decrease in LDL cholesterol, total cholesterol or blood triglycerides, and their results were similar to those of people who took a placebo. While there were similar adverse events in all the groups, there were a numerically higher number of problems among those who took the plant sterols or red yeast rice.

“We designed this study because many of us have had the same experience of trying to recommend evidence-based therapies that reduce cardiovascular risks to patients and then having them say ‘no thanks, I’ll just try this supplement,’ ” said study co-author Dr. Karol Watson, professor of medicine/cardiology and co-director, UCLA Program in Preventive Cardiology. “We wanted to design a very rigid, randomized, controlled trial study to prove what we already knew and show it in a rigorous way.”

Dr. Steven Nissen, a cardiologist and researcher at the Cleveland Clinic and a co-author on the study, said that patients often don’t know that dietary supplements aren’t tested in clinical trials. He calls these supplements “21st century snake oil.”

In the United States, the Dietary Supplement and Health Education Act of 1994 sharply limited the US Food and Drug Administration’s ability to regulate supplements. Unlike pharmaceutical products that have to be proven safe and effective for their intended use before a company can market them, the FDA doesn’t have to approve dietary supplements before they can be sold. It is only after they are on the market and are proven to be unsafe that the FDA can step in to regulate them.

“Patients believe studies have been done and that they are as effective as statins and can save them because they’re natural, but natural doesn’t mean safe and it doesn’t mean they’re effective,” Nissen said.

The study was funded via an unrestricted grant from AstraZeneca, which makes rosuvastatin. The company did not have any input on the methodology, data analysis and discussion of the clinical implications, according to the study.

The researchers acknowledged some limitations, including the study’s small sample size, and that its 28-study period might not capture the effect of supplements when used for a longer duration.

In a statement on Sunday, the Council for Responsible Nutrition, a trade association for the dietary supplement industry, said “supplements are not intended to replace medications or other medical treatments.”

“Dietary supplements are not intended to be quick fixes and their effects may not be revealed during the course of a study that only spans four weeks,” Andrea Wong, the group’s senior vice president for scientific and regulatory affairs, said in a statement.

Dr. James Cireddu, an invasive cardiologist and medical director of University Hospitals Harrington Heart & Vascular Institute at University Hospitals Bedford Medical Center, said the work is going to be helpful.

“They did a nice job collecting data and looking at the outcomes,” said Cireddu, who did not work on the study. “It will probably resonate with patients. I get asked about supplements all the time. I think this does a nice job of providing evidence.”

Dr. Amit Khera, chair of the AHA Scientific Sessions programming committee, did not work on the research, but said he thought this was an important study to include in the presentations this year.

“I take care of patients every day with these exact questions. Patients always ask about the supplements in lieu of or in addition to statins,” said Khera, who is a professor and director of preventive cardiology at UT Southwestern Medical Center. “I think if you have high quality evidence and a well done study it is really critical to help inform patients about the value, or in this case the lack of value, for some of these supplements for cholesterol lowering.”

Statins have been around for more than 30 years and they’ve been studied in over 170,000 people, he said. Consistently, studies show that statins lower risk.

“The good news, we know statins work,” Khera said. “That does not mean they’re perfect. That doesn’t mean everyone needs one, but for those at higher risk, we know they work and that’s well proven. If you’re going to do something different you have to make sure it works.”

With supplements, he said he often sees misinformation online.

“I think that people are always looking for something ‘natural’ but you know there’s a lot of issues with that terminology and most important we should ask do they work? That’s what this study does,” Khera adds. “It’s important to ask, are you taking something that is proven, and if you’re doing that and it’s not, is that in lieu of proven treatment. It’s a real concern.”

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Health

High blood pressure went up even more early in the pandemic, study finds

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CNN
 — 

People in the US with high blood pressure saw their levels rise during the first eight months of the Covid-19 pandemic, a new study says.

When someone has high blood pressure, the force of their blood pushes against the walls of their blood vessels, making their heart less efficient. Both vessels and heart must work harder. Without treatment, high blood pressure will eventually damage the arteries, raising the person’s risk of a heart attack or stroke.

Heart disease is the No. 1 killer in the world, and well-controlled blood pressure is the leading modifiable risk factor, according to the researchers on the new study, published Tuesday in the journal Hypertension.

The US National Institutes of Health, which helped fund the study, said it is one of the most extensive looks at blood pressure trends from the beginning of the pandemic.

The researchers looked at the records of more than 137,000 adults with high blood pressure and compared their levels from August 2018 to January 2020 with their levels from April 2020 through January 2021. The records came from Cedars-Sinai Medical Center in Los Angeles, Columbia University Irving Medical Center in New York City and Ochsner Health in New Orleans. The participants, on average, were 66 years old. More than half were women, and 30% were Black.

Blood pressure is measured in millimeters of mercury (abbreviated as mmHg). The measurement has an upper number, or systolic reading, and a lower number, a diastolic reading.

Systolic pressure measures the force of blood as it pumps out of the heart into the arteries, and diastolic is the pressure created as the heart rests between beats. High blood pressure is defined as a systolic pressure over 140mmHg and a diastolic blood pressure over 90 mmHg.

In the study, the patients’ systolic readings rose 1.79 mmHg, on average, and their diastolic readings went up an average of 1.30 mmHg.

“Although these increases appear small, studies show that just a 2 mmHg increase in blood pressure can raise the risk of major cardiovascular events by as much as 5%,” the NIH said in a news release.

The overall rise in numbers was “smaller than expected,” said study author Dr. Hiroshi Gotanda, an assistant professor in the division of General Internal Medicine at Cedars-Sinai Medical Center.

Gotanda thinks the expansion of telemedicine during the pandemic may have helped. Other studies have found that telemedicine is an effective alternative to an in-person doctor visit to manage high blood pressure.

Because high blood pressure doesn’t always cause symptoms, people who have it are encouraged to monitor their numbers at home. If they have a doctor’s appointment, they may be more mindful about keeping track so they have something to report. And during an appointment, doctors can change their prescription if their blood pressure is consistently high.

In the first three months of the pandemic, the study found, people weren’t checking their blood pressure at home as much as they had been. Measurements declined as much as 90% from before the pandemic. The number of checks went up over time, but even at the end of the study period, the measurements were still below pre-pandemic levels.

The study had some limitations, including that it measured only people who were able to access health care. Those without health care or insurance may have had a different result.

“The impact of the pandemic on their blood pressure might have been much larger,” Gotanda said.

The study doesn’t suggest why blood pressure levels went up, and it’s hard to tell on an individual basis, Gotanda said. But it may involve pandemic-related changes in routines.

Dr. Eduardo Sanchez, the American Heart Association’s chief medical officer for prevention, offered some other reasons: “Clinical care visits declined dramatically in the early months of the pandemic – delayed care seeking by patients and reduced access by some clinical care providers. Patient behavior was driven by their interpretation of COVID prevention messages and fear of COVID. Early on, job loss may have contributed to less care and not filling prescriptions. Visits have been increasing and blood pressure control is increasing but lagging.”

Additionally, studies show that people have gotten less sleep – and less quality sleep – during the pandemic. With gyms closed and people staying home more, they exercised less, had less-healthy diets and drank more alcohol.

Gotanda said the researchers hope to look next at what impact even this slight blood pressure increase will have on a patient’s overall heath. They also want to know which of the patients may have had a hard time accessing telemedicine.

Telemedicine could have a broad impact. Nearly half of adults in the United States have high blood pressure, according to the US Centers for Disease Control and Prevention, and about half of those have what doctors consider uncontrolled high blood pressure. That’s about 37 million adults – and with the ongoing obesity epidemic, the number will probably grow.

High blood pressure can be genetic, but there are things you can do to keep it in check. Keeping a close eye on your numbers is the first step, the American Heart Association recommends. People who know their numbers can make changes if they need.

Medication can treat high blood pressure, and lifestyle changes could help, like stopping smoking or vaping, managing stress, keeping a healthy weight and eating a heart-healthy diet.

A heart-healthy diet is high in vegetables, whole grains and low-fat dairy, and low in salt, saturated fat, red meat and sweets. It’s also one that keeps alcohol to a minimum. The American Heart Association suggests no more than two drinks per day for men, one for women.

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Drinking caffeine while pregnant impacts child’s height: Study

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CNN
 — 

Starting the day with a hot cup of caffeinated coffee or tea may sound divine to some, but it could have negative impacts for the children of people who are pregnant, according to a new study.

Children who were exposed to small amounts of caffeine before birth were found on average to be shorter than the children of people who did not consume caffeine while pregnant, according to the study published Monday in JAMA Network Open.

Children of parents who consumed caffeine while they were in the womb were shown to be shorter in stature at age 4 than those whose parents did not — and the gap widened each year through age 8, according to lead author Dr. Jessica Gleason, a perinatal epidemiologist.

“To be clear, these are not huge differences in height, but there are these small differences in height among the children of people who consumed caffeine during pregnancy,” said Gleason, who is a research fellow at Eunice Kennedy Shriver National Institute of Child Health and Human Development.

The American College of Obstetricians and Gynecologists currently recommends limiting caffeine consumption to less than 200 milligrams per day while pregnant.

For context, a mug of caffeinated tea typically has about 75 milligrams of caffeine, a mug of instant coffee has about 100 milligrams and a mug of filtered coffee has about 140 milligrams, according to the Cleveland Clinic. And even chocolate has about 31 milligrams of caffeine.

But the differences found in the most recent study were found even in the children of parents who drank less than half a cup of coffee per day while pregnant — well below the current guidelines, Gleason said.

It’s not clear whether this study effectively shows causation between maternal caffeine consumption and child height, according to Dr. Gavin Pereira, a professor of epidemiology and biostatistics at Curtin University in Australia. Pereira was not involved in the study.

“The correlation observed in this study can be explained by the existence of a common cause of both caffeine consumption and growth restriction e.g., poverty, stress, and dietary factors,” said Pereira in a statement to the Science Media Centre.

If shorter height in early childhood were to persist into adulthood, there would be a chance those children could face the risk of poor cardiometabolic outcomes, such as heart disease and diabetes, which are associated with smaller stature.

But there is still no way to know if the difference would persist into adulthood, and studies like this that focus on population outcomes are no reason for individual families to panic, Gleason said.

These population-level trends should instead be taken together with other research for organizations to reassess their recommendations, Gleason said.

In the past, there were inconsistent studies regarding whether consuming caffeine during pregnancy impacted the fetus, but the evidence has come together in recent years, Gleason said.

A 2015 meta-analysis that reviewed all of the existing research found there is a dose response association between consumption of caffeine and smaller birth size. And a 2020 study revealed there is no safe level of caffeine for a developing fetus.

Even without the panic that Gleason cautioned against, some people might want to cut back on caffeine — and then find that it’s easier said than done.

Remember, caffeine is found in coffee, tea, soft drinks, energy drinks and shots, as well as cocoa and chocolate. It’s also present in fortified snack foods, some energy bars and even some pain medications. (For a more extensive list of caffeine content from various sources, check the chart from the Center for Science in the Public Interest.)

A 2016 Johns Hopkins University study found that it was helpful when individuals identified situations or moods in which they are most likely to crave caffeine so they could avoid situations that trigger cravings, especially during the first few weeks of modifying caffeine use. Caffeine drinkers could also have a plan for when cravings occur, like taking a five-minute relaxation break involving deep-breathing exercises.

Remember to always discuss any major lifestyle or dietary changes with your health care provider first, as changes may affect your mood or medical conditions.

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Health

Drinking caffeine while pregnant impacts child’s height: Study

Leave a comment

Editor’s Note: Sign up for CNN’s Eat, But Better: Mediterranean Style. Our eight-part guide shows you a delicious expert-backed eating lifestyle that will boost your health for life.



CNN
 — 

Starting the day with a hot cup of caffeinated coffee or tea may sound divine to some, but it could have negative impacts for the children of people who are pregnant, according to a new study.

Children who were exposed to small amounts of caffeine before birth were found on average to be shorter than the children of people who did not consume caffeine while pregnant, according to the study published Monday in JAMA Network Open.

Children of parents who consumed caffeine while they were in the womb were shown to be shorter in stature at age 4 than those whose parents did not — and the gap widened each year through age 8, according to lead author Dr. Jessica Gleason, a perinatal epidemiologist.

“To be clear, these are not huge differences in height, but there are these small differences in height among the children of people who consumed caffeine during pregnancy,” said Gleason, who is a research fellow at Eunice Kennedy Shriver National Institute of Child Health and Human Development.

The American College of Obstetricians and Gynecologists currently recommends limiting caffeine consumption to less than 200 milligrams per day while pregnant.

For context, a mug of caffeinated tea typically has about 75 milligrams of caffeine, a mug of instant coffee has about 100 milligrams and a mug of filtered coffee has about 140 milligrams, according to the Cleveland Clinic. And even chocolate has about 31 milligrams of caffeine.

But the differences found in the most recent study were found even in the children of parents who drank less than half a cup of coffee per day while pregnant — well below the current guidelines, Gleason said.

It’s not clear whether this study effectively shows causation between maternal caffeine consumption and child height, according to Dr. Gavin Pereira, a professor of epidemiology and biostatistics at Curtin University in Australia. Pereira was not involved in the study.

“The correlation observed in this study can be explained by the existence of a common cause of both caffeine consumption and growth restriction e.g., poverty, stress, and dietary factors,” said Pereira in a statement to the Science Media Centre.

If shorter height in early childhood were to persist into adulthood, there would be a chance those children could face the risk of poor cardiometabolic outcomes, such as heart disease and diabetes, which are associated with smaller stature.

But there is still no way to know if the difference would persist into adulthood, and studies like this that focus on population outcomes are no reason for individual families to panic, Gleason said.

These population-level trends should instead be taken together with other research for organizations to reassess their recommendations, Gleason said.

In the past, there were inconsistent studies regarding whether consuming caffeine during pregnancy impacted the fetus, but the evidence has come together in recent years, Gleason said.

A 2015 meta-analysis that reviewed all of the existing research found there is a dose response association between consumption of caffeine and smaller birth size. And a 2020 study revealed there is no safe level of caffeine for a developing fetus.

Even without the panic that Gleason cautioned against, some people might want to cut back on caffeine — and then find that it’s easier said than done.

Remember, caffeine is found in coffee, tea, soft drinks, energy drinks and shots, as well as cocoa and chocolate. It’s also present in fortified snack foods, some energy bars and even some pain medications. (For a more extensive list of caffeine content from various sources, check the chart from the Center for Science in the Public Interest.)

A 2016 Johns Hopkins University study found that it was helpful when individuals identified situations or moods in which they are most likely to crave caffeine so they could avoid situations that trigger cravings, especially during the first few weeks of modifying caffeine use. Caffeine drinkers could also have a plan for when cravings occur, like taking a five-minute relaxation break involving deep-breathing exercises.

Remember to always discuss any major lifestyle or dietary changes with your health care provider first, as changes may affect your mood or medical conditions.

Read original article here