Tag Archive for: heart disease

Artificial Sweeteners—Still Your Choice

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The use of artificial sweeteners is always a contentious topic in the health field. Some people hate them, other people love them. I use them occasionally, but when it comes to benefits versus harms, I stick to the research. In this case, it’s what wasn’t stated in the headlines about the study that is important, but we can make a decision based only on what we read. This was an abstract of a presentation at a conference, so some details may have been left out that were included in the study.

The Rest of the Story

The authors established an increased risk of diabetes with artificially sweetened drinks and saccharin in any form, but there were no statistically significant diabetes symptoms linked with total intake of artificial sweeteners, sucralose, or aspartame in all foods. That means that artificial sweeteners used in other foods didn’t raise the risk of diabetes, such as added to coffee, used in ice cream or other dairy products, or used in baking. You have to wonder why it had no apparent impact.

It may be that the specific food delivery system has some impact on why it does or does not have an effect. One possibility is that if the sweetener reaches the gut bacteria, it’s modified in some way so that it doesn’t impact blood sugar or blood sugar release.

It seems odd that they used markers of diabetes as their criteria rather than physician diagnosis. They looked for fasting glucose of 126 mg/dl or more; oral glucose tolerance test 2-hour glucose of 200 mg/dl or more; hemoglobin A1C of 6.5% or more; or use of diabetes medications. The last one makes sense, because you don’t get the meds unless you have a diagnosis, but still, odd language.

FFQ—Again!

Even though the food frequency questionnaire is still a good assessment tool when used with interviews, I checked the validation studies. The correlations with food diaries and interviews for the food frequency questionnaire developed specifically for the CARDIA study were no better than 0.5, indicating a moderate positive relationship—maybe it did, maybe it didn’t. That’s much worse than other correlations used in large studies. Also, the first two nutritional assessments couldn’t have assessed sucralose because it wasn’t available until after they took place; I don’t know why sucralose was included when it wasn’t available for almost half the follow-up period.

The Bottom Line

The debate on artificial sweeteners will go on, because people love them or hate them. Based on the results of this observational study, nothing of worth has really been added to the knowledge base. The researchers called for more research to examine how artificial sweeteners impact glucose metabolism. We don’t know that it does from anything done in this study, but that doesn’t mean well-designed studies shouldn’t be done in the future. Until then, it’s up to you whether to use artificially sweetened drinks or not. Maybe a better idea is to give up the mega-burger and fries instead.

What are you prepared to do today?

        Dr. Chet

Reference:  Cur Devel in Nutr  https://doi.org/10.1016/j.cdnut.2025.107034

Artificial Sweeteners—Again

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“I’ll have the jumbo mega-burger with extra cheese, a large order of fries, and a diet cola.” Have you ever heard that when you’re standing in line? Have you maybe ordered that yourself? That’s what I thought of when I read the health headlines about the dangers of artificial sweeteners contributing to the development of diabetes.

The Coronary Artery Risk Development in Young Adults (CARDIA) study began in the early 1980s by recruiting and tracking young adults to determine which factors are associated with the development of heart disease. Nutrition was one of the primary factors that was tracked using a food frequency questionnaire with dietician interview. They tested the subjects at the beginning of the study, at year 7 of follow-up, and year 20 of follow-up.

After tracking the subjects for almost 25 years, they found that 14.8% of subjects developed metabolic changes that indicated diabetes. Comparing the highest quintile of artificially sweetened drink use with the lowest quintile, there was a 129% increased risk for developing diabetic symptoms in the highest quintile. The use of saccharin was also associated with 120% increased risk of developing diabetes.

Is there more to this study that wasn’t highlighted in the headlines? I’ll cover that in Saturday’s Memo.

What are you prepared to do today?

        Dr. Chet

Reference:  Cur Devel in Nutr  https://doi.org/10.1016/j.cdnut.2025.107034

The Best Heart-Healthy Diet

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In assessing popular diets to find out which one follows the AHA heart-healthy dietary guidelines the best, the panel did a credible job. Instead of just using their expertise, which is substantial, they developed an objective way of assessing each popular diet. They did have one diet that received a point for each of the nine categories thus achieving 100%. That was the Dietary Approach to Stop Hypertension more commonly known as the DASH diet.

The researchers then assessed the dietary patterns and organized them into four tiers based on compliance with the AHA guidelines. I’ll break it down into the tiers for you.

Tier 1

This tier includes the DASH diet, the Mediterranean diet, the pescatarian or fish as protein, and the ovo-lacto vegetarian diets. The primary reason that the DASH diet ranked so high was its ability to get protein from every source: plant proteins such as nuts and legumes, fish and seafood, low-fat or fat-free dairy, and the ability to use lean cuts of all meats. The other diets in Tier 1 either did not recommend proteins from all sources or did not emphasize reducing the amount of salt intake, a key element of the DASH diet.

Tier 2

Tier 2 included the vegan diet and other low-fat diets. Their strength, of course, is the emphasis on vegetables and fruits as well as whole grains, but they all seek to use plant-based protein. Some of the low-fat diets can be quite extreme, such as the Esselstyn Program which restricts fat to less than 10% per day and restricts protein as well.

Tier 3

This included the very low fat diets as well as the low-carbohydrate diets. The reason these two are put together is the restriction on quality protein sources as well as whether people adhere to the diet at every meal.

Tier 4

The paleo diet and very low carbohydrate diets such as the ketogenic diet received the worst scores; that means they fall into the category of not being heart healthy at all.

Other Considerations

The panel also considered three primary issues. The first was how easy it would be to facilitate patients to adapt to the particular diet. To me, the strength of the DASH diet and to some degree the Mediterranean diet is the variety of proteins that can be used. When you get into the very low fat and the very low carbohydrate diet, the restrictions can become overwhelming for most people.

They also considered the challenges for the consumers. In my experience, there are always going to be questions about what could be included in any dietary approach, whether it’s the Mediterranean diet or the ketogenic diet. In order for people to adapt the diet, they need instruction and they need to be able to ask questions; those would be significant challenges when recommending the diets that restrict foods allowed, which could either be vegan, the very low fat, or the ketogenic diet.

The final consideration is the opportunities presented to provide patients with good information about the diet. The problem as I see it is that physicians, physician assistants, and nurse practitioners are not familiar enough with nutrition to be able to do that effectively in a medical practice, especially considering the time constraints for most healthcare practitioners. The obvious choice is to refer it to a dietetics department, but that type of consultation is not very often available in most medical practices and especially under most health insurance programs. I think the challenges are going to take years to overcome.

My Thoughts

I thought the researchers did a credible job in coming up with their recommendations. They analyzed popular diets objectively and assessed them based on the AHA Dietary Guidance.

What is lost is exactly how this is going to help people. Since 1974, more fruits and vegetables and a limit on fat intake were recommended as the foundation of every diet. No matter how many diets have come and gone, no matter how many are yet to be developed, we have not achieved the simplest and yet most obvious objectives. Food manufacturers certainly have had a role to play in this with low-fat and ultra-processed convenience food, but the choice is always with us.

There are three more things that I think must be considered. First would be the individual’s genetic tendencies. We simply don’t know enough about interaction between genes and nutrition and how that impacts input. Second, protein needs change over a lifetime. At some point, proteomics must be considered in dietary recommendations; it isn’t all about your heart.

Finally, they specifically did not consider the potential for weight loss or weight maintenance in every program. Regardless of diet, it was, it is, and it will always be about the calories. If someone can get to a normal body weight and maintain it, I think there might be room for just about any type of diet, providing it provides enough vegetables and fruits.

The Bottom Line

As the lead author suggested in an interview, there were four recommendations across all popular diets: eat whole foods, eat more non-starchy vegetables, eat less added sugar, and eat less refined grains. If we could start with that, I think our hearts would love us for it.

What are you prepared to do today?

        Dr. Chet

Reference: https://www.ahajournals.org/doi/10.1161/CIR.0000000000001146

How Popular Diets Impact Your Heart

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When the American Heart Association (AHA) speaks, news organizations tend to report what they say and people tend to listen. It’s doubly true when they rank all the popular diets according to how they relate to heart health. Because we seem to live in a society based on the “see food, eat food” diet, that can be meaningful. Here’s what a group of experts did to evaluate popular dietary approaches to diet and rank them according to AHA guidelines for a heart-healthy diet.

The AHA has ten dietary guidelines for eating a heart-healthy diet, such as “Eat plenty of vegetables and fruits” and “Choose healthy sources of proteins.” For the complete list, click on this link to the article; the scientific statement is open access on the AHA website.

Then the panel selected the most popular diets in the U.S. such as the Mediterranean diet, the DASH diet, several versions of a vegetarian diet, low-fat, paleo, and ketogenic diet. They gave each diet a full point for following each of the AHA guidelines or partial points depending how closely they followed the guidelines.

This was not an arbitrary assignment by a panel of experts; they used the best information available to determine the best heart-healthy diet. Who got the highest score? Mediterranean? Vegan? Ketogenic? I’ll let you know on Saturday along with my thoughts on the diets. One thing’s for certain: eat your fruits and vegetables. You may as well start with that right now.

What are you prepared to do today?

        Dr. Chet

Childhood Obesity: A Family Thing

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I hope you took some time to scan the Executive Summary of American Association of Pediatrics Guidelines for Physicians. If you couldn’t, here are the three things that stood out to me.

Screening by Pediatricians and Primary Care Physicians

The focus of the guidelines was to assess risk factors for degenerative disease such as heart disease and diabetes in children who exceed the 85th percentile of the normal growth charts, indicating overweight, and 95th percentile, indicating obesity. The guidelines recommend beginning at 2 years of age and continuing through 18.

Were there recommendations for the use of medications and bariatric surgery in children over 12 and 14 respectively? Yes, but they were referrals to specialists for evaluations, not a blank invitation to write prescriptions.

It Must Be a Family Thing

Without exception, the guidelines recommend intensive health behavior and lifestyle treatment. “Health behavior and lifestyle treatment is more effective with greater contact hours; the most effective treatment includes 26 or more hours of face-to-face, family-based, multicomponent treatment over a three- to twelve-month period.”

That’s not the same as giving Mom and Dad a diet for the child and sending them on their way. Family-based programs have demonstrated great success, but it has to be a family thing.

It’s All About the Money

The summary also talked about obstacles to the family-based treatment approach. The major obstacle is money:

  • Money for training pediatricians and family practice physicians on how to assess childhood obesity.
  • Money for training more people to teach and work with families—it’s labor intensive.
  • Money for public health and community programs that can support the family-based approach.

It’s a situation we’ve seen many times: Everyone knows how important preventive healthcare and early treatment is, but no one wants to pay for it. But maybe we shouldn’t always look to government to foot the bill; maybe schools, community organizations, and churches could offer programs for their members. If what we’ve always done isn’t working, let’s try something different.

The Bottom Line

The guidelines introduce a couple of new approaches for those with the most severe weight problems, but the focus is on intensive nutrition and behavior-change training for the entire family. That’s not just “Here’s a diet and exercise program, and I’ll see you next year.” The guidelines give a reasonable approach to help the future health of the nation. The approach is simple: Eat less. Eat better. Move more. What they’re saying is that healthcare professionals need training to be able to do that effectively as a team in a reasonable family-based approach. That’s the right approach as I see it.

What are you prepared to do today?

        Dr. Chet

Reference: Pediatrics e2022060641.https://doi.org/10.1542/peds.2022-060641

Omega-3s and Cardiac Events

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There was another study this week on omega-3 fatty acids. While the study I talked about last Thursday was small with only 21 subjects, this trial contained over 13,000 subjects from 675 hospitals and clinical centers all around the world. In this five-year study, one of the omega-3 fish oil medications was being tested to see if it would reduce cardiac events such as heart attacks, stroke, and death when compared with subjects taking a corn-oil placebo. The study was stopped early when it was clear there were going to be no significant differences in any of the outcomes that were being studied. In other words, the prescription fish oil did not reduce cardiovascular disease events.

While that may seem disappointing, there are some factors that most likely impacted the outcome and a couple that may have but could not be tested.

The Subject Pool

The subjects in this clinical trial had significant risk for CVD; they were required to have established coronary artery disease or significant risk factors to be included in the clinical trial. Those risk factors included being a type 1 or type 2 diabetic, with at least one additional risk factor including chronic smoking, hypertension, hs-CRP higher than two mg/L, moderately increased protein loss, or being older with similar factors as the diabetics.

The Data Not Collected

In reading the study, there were three criteria that came to mind that could have impacted the outcome if the corresponding data had been collected and considered in the statistical analysis. I emailed the relevant author and got the answers.

1. Were data collected on exercise habits of the subjects? No.

2. Were nutritional data collected on the subjects? No.

3. Was the form of omega-3 used, a highly purified carboxylic acid form, assessed as to how the metabolism impacts the omega-3s’ mechanism of action? No.

It seems to me that if the data could be analyzed on exercisers versus sedentary as well as using nutritional factors, even just daily caloric intake, there may have been significant results. As for the form of omega-3s, the CA form is highly absorbed and doesn’t require a fat in the diet to assist with that process. There might have been something else that happens during metabolism that normally assists in the risk reduction. We just don’t know.

The Bottom Line

The authors acknowledge that this subject pool was at high risk for cardiac events. One explanation is that the progression of disease may have already been too advanced and could have impacted the efficacy of the medication. For people with less established CVD, the omega-3s might have been more effective.

Many in the medical field wrote about the failure of omega-3s in medication or supplement form to prove that they have any impact on CVD events or mortality. I think they’re wrong. The one outcome they never test is the quality of life. Granted, it’s difficult to assess but if people can live their lives even 10% better, regardless of CVD events, that seems worth it. Paula and I are still taking our omega-3 supplements; in fact Riley takes one, too, even though he’s only five and we’re not concerned about his heart. Whether you’re worried about your heart or not, omega-3s have many benefits. This study shows no reason why you or I should stop taking them.

What are you prepared to do today?

        Dr. Chet

Reference: JAMA. 2020;324(22):2268-2280. doi:10.1001/jama.2020.22258

It’s Official: Prescription Fish Oil

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The U.S. Food and Drug Administration approved the prescription fish oil Vascepa for expanded use on Friday, December 13. The approval for the medication is for the secondary prevention of cardiovascular disease in patients under the following conditions:

  • Triglycerides above 150 mg/dl for everyone with diagnosed CVD and taking a statin medication.
  • Diabetes and two or more additional risk factors for CVD along with taking a statin medication.

The modifiable risk factors for CVD include smoking, obesity, high cholesterol, hypertension, and sedentary living. Remember from our prior series, secondary prevention may help reduce the risk of CVD symptoms developing.

My concerns are the same as they were before. Triglycerides less than 250 mg/dl can be resolved by diet and exercise in most people. Because the mechanism of action is unknown as to how the prescription works, there’s no reason to think that reducing triglycerides by lifestyle change won’t work as well as the prescription; the clinical trial didn’t track this data.

Speaking of lifestyle change, keep in mind the website specials on the Optimal Performance program as we get ready for the New Year. The Basic Meal Plan will teach you how to change your diet to reduce triglyceride levels if your levels are too high.

What are you prepared to do today?

        Dr. Chet

References:
1. http://bit.ly/36EbsYK
2. N Engl J Med 2019;380:11-22. DOI: 10.1056/NEJMoa1812792.

Prescription Fish Oil: Questions Remain

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The REDUCE-IT clinical trial formed the basis for the expanded recommendations for use of Vascepa, the prescription fish-oil medication. This was an expensive trial, involving 11 countries and hundreds of medical centers with 999 physicians who recruited subjects, collected data, and kept track of the subjects for close to five years. With over 8,000 subjects, this was no easy task. As I said in Thursday’s Memo, they examined the primary and secondary prevention when the medication is taken with statins versus a placebo with statins.

While this was a tremendous effort, there are still some concerns, in my opinion.

Study Concerns

A board made up of physicians and the pharmaceutical company’s staff designed the study and helped execute it; the pharmaceutical company paid for the clinical trial, collected and managed the data, analyzed the data, and interpreted the results. Then the statistics were reviewed by an independent statistician. This creates a huge conflict of interest regardless of safeguards that may have been put in place.

When any type of study is supported by companies with vested interests in the outcome, there will always be questions. That has been true for every dietary supplement manufacturer that’s ever funded a study as well as the milk and sugar industry. It’s especially true for this study. I began by talking about a report from the financial sector. Billions of dollars are on the line. That has to be considered by the FDA before final approval is given.

I have a tendency to have faith in science, as skeptical as I may be at times. And that’s where my concerns lie; not in the financial aspect but in the study design and results.

My Concerns

As complicated as this study was, it was incomplete in my opinion. They did not collect any data on the subjects’ diet; a small change in diet could have reduced triglycerides (TG) enough to have a positive impact on secondary outcomes. The median change in TG over five years with the medication was 45 mg/dl, from about 215 down to 170 in the medication group, while it was reduced 13 mg/dl in the placebo group. We don’t know whether a group that focused on dietary changes to reduce TG would have the same reduction in CVD events; that would have been an excellent addition to the study design.

They also didn’t have a group using fish oil from dietary supplements. True, it’s not their responsibility, but we can’t know whether the same benefit might not occur if the dosing of EPA were equal:

  • Almost every study that has used fish oil to examine whether CVD outcomes could be reduced has used fish oil with 1 gram of EPA.
  • If the amount of EPA were the same, a head-to-head comparison between a supplement and medication that each had 4 grams EPA might have found a similar benefit.

The real issue is that we don’t know what makes the fish-oil medication work, just like we don’t know completely how dietary omega-3 fatty acids work. Is it just the reduction in the TG or how the oils work in the body? Are genetics involved? Diet? The microbiome? We have no idea at this time.

The Bottom Line

I’ll keep on eye on the approval process for this fish-oil pharmaceutical and let you know how it will be prescribed in the future. The decrease in TG found in the study can be done with lifestyle changes alone, so is it going to be worth the cost of a pharmaceutical for a slight reduction in CVD events? Remember the difference between medication and placebo was just 4.8%. If you fall in that category, you’ll have to decide for yourself: pharmaceutical fish oil or lifestyle change. In this case, a little work may go a long way.

What are you prepared to do today?

        Dr. Chet

P.S. This will be the last Memo until after Thanksgiving. Paula and I are doing something we haven’t done in 20 years: go on a real vacation, just us, just for fun. No work of any type. Talk to you again December 3.

Reference: N Engl J Med 2019;380:11-22. DOI: 10.1056/NEJMoa1812792.

Primary vs. Secondary Meds

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One of the key questions for the FDA advisory panel to consider was whether the prescription fish oil was a primary preventer of cardiovascular disease or a secondary preventer. What’s the difference? Primary prevention of CVD would impact the disease and stop events before they occurred in the subjects taking the fish-oil medication. Secondary prevention would prevent additional CVD events from happening in those with established CVD.

If you were a type 2 diabetic with an additional risk for CVD such as obesity or being a smoker, taking the prescription fish oil with a statin would prevent a heart attack or stroke from happening; that’s primary prevention. Based on the Reduction of Cardiovascular Events with Icosa-pent Ethyl–Intervention Trial (REDUCE-IT) that didn’t happen, but it did prove to be a secondary preventer of additional cardiac events in those subjects in the study with established disease.

The question is whether the FDA will approve the prescription fish oil as a primary prevention or a secondary prevention pharmaceutical. The advisory panel seemed split on that count. The assumption by some was that there was disease present even though the event had yet to occur. Others said “prove it” by doing an actual clinical trial to examine that question. We’ll find out how the FDA decides later this year. As I mentioned yesterday, the financial implications are huge.

There are still some things to consider with the clinical trial, and I’ll cover that on Saturday.

What are you prepared to do today?

        Dr. Chet

Reference: N Engl J Med 2019;380:11-22. DOI: 10.1056/NEJMoa1812792.

Prescription Fish Oil Update

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“This Fish-Oil Heart Drug Could Be Big, Could Be Huge.” That was the headline in a well-known financial report after a Food and Drug Administration panel unanimously voted in favor of an expanded use for the prescription fish-oil drug. I mentioned this was a possibility when I first talked about Vascepa in October. The FDA is expected to make a final decision by the end of the year.

What is the expanded use? The medication could be prescribed to those who have established heart disease or type 2 diabetes with another CVD risk factor and are already taking statin medications to lower cholesterol. The advisory panel approved the use because research showed that when combined with statins, it could reduce CVD endpoints such as death, heart attacks, and strokes by an additional 4.8% when compared to a placebo over a 4.9 year follow-up period, 17.2% versus 22%.

One more thing. The medication could be prescribed to those with triglycerides as low as 150 mg/dl. That would include millions more potential users in the U.S. and Canada alone. You can see why the headline was in the financial news; the potential profit for investors could be huge. A lot is riding on what the FDA decides. I’ll explain that on Thursday.

What are you prepared to do today?

        Dr. Chet

Reference: Bloomberg Online. Max Nisen. Posted 11-15-2019.