Product Claims for GOLO

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Another ubiquitous commercial on television is for a weight loss program called GOLO for Life, a dietary supplement and a weight loss program. It’s the one that uses an illustration to explain insulin resistance: the muscle in the abdominal area is blocked from using belly fat by a barrier. Insulin resistance is much more complicated than that, but I guess it makes a point. The claim in an expanded version of the commercial on the GOLO website is that “the program is clinically proven to reduce insulin resistance.” There are many more claims, but I’m going to stick with that one.

The company supported four studies on the GOLO for Life program; I’ll cover the two pilot studies today—one in the U.S. and another in South Africa—and the remainder on Saturday.

The U.S. pilot study did not have a control group, had a significant number of dropouts, and did not report the caloric intake of the subjects. The subjects lost a significant amount of weight and lowered their HbA1c by 4%.

The South African study was not so much a study as a series of GOLO programs conducted as part of wellness programs in businesses. The data were combined for analysis. Again, there were significant dropouts and caloric intake was not reported. The subjects using the supplement lost more weight than the controls.

Why did I make a big deal about caloric intake? If we don’t know how much they claimed they ate, we don’t know whether to attribute the results to the supplement or the weight loss program or both. The purpose of pilot studies is to help set up clinical trials, and we’ll take a look at those on Saturday.

What are you prepared to do today?

        Dr. Chet

Research on Health and Apple Cider Vinegar

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Watching more television than usual means I’m seeing more commercials than I’m used to seeing. It’s time to take a look at some dietary supplements that make health claims in television commercials. I’m going to focus on the science behind any claims being made on the product label or on the product’s website to see if they pass the FDA regulations. The product claims are worded as the FDA suggests; the question is whether the science is substantial enough to make the type of claims the FDA allows.

The first product is Goli, an apple cider vinegar (ACV) gummy supplement. The website makes claims about weight loss, appetite control, blood sugar control, energy, immune function, detox, gut health, skin, and heart health. I chose to examine heart health.

The company used three studies to support the claim. The first examined the use of 750 and 1,500 mg of ACV in a drink. The results showed no clear pattern of benefit although triglycerides went down. The second study compared a group using ACV plus calorie reduction with a control group that had no intervention; in this case, the restricted calories could explain any benefits. Finally, they used data from the Nurses Health Study that reported better heart outcomes in women who used oil-and-vinegar salad dressing. The focus of that research was on the type of oil, not the type of vinegar.

Based on the FDA Guidelines, claims cannot be made from research that uses an ingredient in food as the substantiation for a benefit from a dietary supplement. I checked the research on several of the other claims they made and the research they used, and I came to the same conclusion. They may be very tasty gummies, but the research does not appear to support the claims they make. But if you want to take a gummy or two to reduce your appetite, our grandson Riley recommends sour gummy worms. Just FYI.

What are you prepared to do today?

        Dr. Chet

References:
1. Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act. https://bit.ly/2QLDRa2
2. Biosci, Biotechnol, Biochem. 2009; 73(8):1837-1843.
3. https://doi.org/10.1016/j.jff.2018.02.003.
4. Journal of the American College of Nutrition, 2001; 20:1(5-19).

Eliminating Pain

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Chronic pain afflicts us all at some time. I’ve talked about my knee enough to write a book, but pain can be in many areas: lower back, shoulders, feet, hips, wrists, and deep muscle pain as might occur from fibromyalgia. Should you give the pain time to work itself out? No—that’s the worst thing you can do, because you may be setting yourself up for years of pain that could have been prevented.

Pain Pathways

Chronic pain may develop when pain pathways become established without intervention. While complicated in nature, what happens is that the series of biochemical reactions and different types of sensory neurons that let your brain know that something is painful get stuck in the “on” position. The original cause, whether from an injury, surgery, or a disease or condition, may have healed, but the nerve fibers are still sending pain signals. In order to affect changes in those pain pathways, you must take action.

Relieve the Pain

This seems obvious, but too many people refuse to do it. What I mean is that whether you’ve been prescribed pain medication or use over-the-counter medications, take them regularly. You don’t get hero badges for avoiding medications and staying in pain. You’re also not limited to medications.

There are many supplements that work for some people, including high-EPA omega-3 fish oil, glucosamine and chondroitin, tart cherry juice, turmeric, and others. If you’re going to take them, be consistent. We also now have CBD oil for internal use and creams and sprays for topical use. Some people find it works well for them, while for others they don’t work at all. How to know? Try each one.

If you can relieve the pain, you can return the area to normal functioning. This is especially true for muscles and joints. When you’re in pain, you compensate by changing the way move. That makes matters worse over the long haul. I’m not suggesting that you will be completely pain free, but if you’re able to move better, that will help you with the second part of pain management.

Rehabilitate

If you’ve had surgery on joints or soft tissue, you had to go through a physical therapy program to restore range of motion and function. The exercises that you were given were supposed to continue until you had a complete return to joint function. Most people get part way there and then stop. My father-in-law had surgery on both shoulders; he completely rehabbed his right shoulder after rotator cuff surgery, but he stopped short with his left. As a result, he could get close to putting his right arm fully extended overhead but got to only about ear level with his left.

Besides stretching to get back range of motion, you can also strengthen the muscles directly involved in the motion as well as those that provide stability to the joint. As just one example, the rotator cuff muscles do just that: they rotate the humerus. But the biceps, triceps, pectoralis major, and deltoid all provide stability to the shoulder. The best thing to do is to check with a physical therapist, most likely using an online video service these days, and get the exercises if you don’t know them. Then get to work.

The Bottom Line

In order to live your life fully, you must deal with chronic pain. The keys to pain management are to

  • Reduce the pain
  • Work on improving your movement of the area involved
  • Work on strengthening the area and surrounding tissues
  • If all else fails, consult a pain specialist.

That’s my goal for the next 60 days: to take a weakness and make it as strong as possible without causing any damage. Progress slowly and be methodical in the approach, and if that doesn’t work, get a referral to a pain clinic. Your life is too important to let pain rule you.

What are you prepared to do today?

        Dr. Chet

Citations Are Important

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When I wrote the first Memo on citrus fruit last week, I omitted part of the date from the citation found at the bottom of every Memo that cites a study or publication. Only a single person noticed. As I wrote in response, sometimes you look at something so many times you don’t see what’s wrong. She noticed because she typically looks up research and wanted to see if it was something she had read before.

From the time I was in graduate school, I’ve always tried to get citations right, especially those that refer to scientific journals. I’ve been on too many frustrating walks through the stacks in research libraries to cause that kind of grief for someone else.

Today you can search databases of journals quite easily. That is, unless you’re given an incomplete citation or worse, just the name and the year—and the year is wrong. I’ll try to make sure I triple-check them from now on. But please, once in a while, look up the research paper or book and take a look at the research paper yourself. You might find you enjoy it.

What are you prepared to do today?

        Dr. Chet

Does Vitamin C Increase Melanoma Risk?

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Last week’s Memos on citrus fruits raised an obvious question; one reader mentioned it, so I thought I should write about it. Here’s the question: was vitamin C examined for any possible relationship with the development of melanoma? Yes, but take a look at what the researchers wrote in the set-up for the study.

After examining the research, they found that vitamin C is toxic for melanoma cells; it kills melanoma cells via multiple pathways and prevents them from multiplying. These are all test-tube studies but still give some indication of the potential role within the body. Because of the prior research, they hypothesized that any increased risk for getting melanoma was related to other compounds in citrus fruit, such as the phytonutrients, and not the vitamin C.

As you would expect, vitamin C levels increased as more citrus fruit was eaten. However, the risk of melanoma didn’t rise as the vitamin C levels from fruit and supplements increased. That confirmed it was some other aspect of the fruit that led to a higher rate of melanoma.

Let’s be sure that we don’t interpret the results to mean that we should megadose on vitamin C to prevent melanoma; the research definitely does not say that. But the skin is connective tissue, so it may be prudent to take additional vitamin C, glucosamine, and collagen to protect your skin, especially if you’re a sun-lover.

This study is also a reminder that our diet needs to be balanced. Too much of anything—even something as healthy as citrus fruit—can lead to problems. Everything in moderation.

What are you prepared to do today?

        Dr. Chet

Reference: J Clin Oncol 2015; 33:2500-2508.

My Clementine

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In doing the background research on whether citrus increases the risk of melanoma enough to be a real concern, there was one more important study that was published this year. The same basic group of researchers who did the original examination of citrus intake in the two large healthcare professional studies added one more component. They used a database of FURs (furocoumarins) levels from 10 different foods that were included in the food frequency questionnaire and re-examined the data. This time, there was no relationship between FUR and melanoma; there was a small relationship with basal cell carcinoma but nothing of great significance.

I’m still going to eat my clementine every morning and drink my energy drink that has grapefruit juice in it when I want to. But these studies did raise at least two questions.

The Furocoumarins Database

The database was constructed by selecting foods that were suspected of having high FUR levels, which makes sense. The chemical analysis of each food is above my pay grade, but let’s assume it’s accurate since no one questioned it in the years since that study was completed. They purchased the foods for analysis from 17 different grocery stores in Connecticut and then analyzed three different samples of the same food purchased from different stores. All good.

The issue is that phytonutrient content can vary based on the season of the year, the ripeness of the fruit or vegetables, even the time of day it was harvested. FURs are stress-induced molecules. After harvesting, FUR levels can be affected by many factors ranging from ultraviolet light exposure to insect infestation. The levels can also vary by the variety of the fruit or vegetables. Then, when it comes to juice, there are processing and storage factors to consider. None of that was considered in the database study.

To be fair, buying foods that we actually eat is the right thing to do. But as a grocery shopper, you know that you can purchase two identical containers of food with two different expiration dates. That has to be accounted for, even if only to find out it doesn’t make a difference. In the case of FURs, it appears the date matters, based on prior research.

Food Frequency Questionnaires

If you’ve been reading the Memo for any length of time, you know that I’m not a big fan of food frequency questionnaires for the way they’re typically used today. The FFQ was designed to give an overall estimate of what people eat, but it’s not a measurement of what people actually ate. When you want to know the overall servings of citrus a person eats, fine. When you begin to break it down into extremely discrete serving portions, that’s where things fall apart in my opinion. Think of how many of these large studies that have used the FFQ that have gotten results that indicate nutrients are associated with some disease or another. In other studies, the reverse is true.

The reason that these are imprecise is because they were validated with a low number of subjects: 173 for one FFQ and 150 for another. The correlation coefficients are just not high enough to put a lot of faith in the FFQ for anything other than a general idea of diet. I’ve got a lot more to say about the topic but this isn’t the forum.

In addition, I think we’d be foolish to overlook the fact that the places where citrus grows in the backyard, and is therefore more convenient and available, are the same places that get more sunny days every year and more intense sun. The researchers controlled for self-reported sun exposure, but I’m almost as skeptical about that as about FFQs.

The Bottom Line

Based on the sum total of all the research, FURs are in some way related to the development of skin abnormalities, especially if you spend a lot of time in the sun. But given all the issues with the FFQ, at least in my opinion, it isn’t enough to avoid citrus if you typically eat or drink it. Pass my clementine, please.

What are you prepared to do today?

        Dr. Chet

References:
1. J Clin Oncol 2015:33:2500-2508.
2. Nutr Cancer. 2020;72(4):568-575.
3. J Food Science. 2011. doi.org/10.1111/j.1750-3841.2011.02147.x
4. J. Agric. Food Chem. 2017, 65, 24, 5049-5055.

Are Furocoumarins the Problem?

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If you’ve been reading the Memos for any length of time, you know I talk about phytonutrients a lot. They’re chemicals in plants that help the plant protect itself against threats such as bacteria, insects, birds, and anything that wants to eat them—such as humans. You might also believe that all phytonutrients are safe and beneficial. That might not be true. Let me explain.

The purpose of the studies on citrus consumption and skin cancer was related to the observation that a class of phytonutrients called furocoumarins (FUR) could be related to an increase in skin cancer, especially melanoma. It turns out that these phytonutrients are photosensitive; when exposed to light, they may cause damage to cell layers. Furocoumarins have been used as a treatment for psoriasis. And one of the major sources of FUR is citrus fruit.

In the study I mentioned Tuesday, the study found a 36% increase in cases of melanoma in those who consumed the most citrus, specifically grapefruit, compared to those who consumed the least. In a similar study on the subject in the Women’s Health Initiative, eating and drinking citrus resulted in a 12% increase in cases of melanoma over 15 years. That assumes that the fruit and juice actually contained the furocoumarins. More about that on Saturday.

What do the results mean for us? In 2016, 22 out of every 100,000 people had some form of melanoma. A 36% increase in the rate would mean that 30 out of every 100,000 people would be affected, and a 12% increase would be 26 out of every 100,000 people. Remember, that risk is for those who consumed citrus every day for 24 and 15 years respectively. As you might expect, nothing is as ever as simple as it seems as you’ll find out on Saturday.

What are you prepared to do today?

        Dr. Chet

References:
1. J Clin Oncol 2015:33:2500-2508.
2. Nutr Cancer. 2020;72(4):568-575.

Does Citrus Increase Melanoma?

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I could write about COVID-19 every week, but health is more than dealing with a viral pandemic, and it’s important we don’t neglect other aspects of our health while we try to keep ourselves safe. When the news and developments warrant, I’ll do an audio update so you can download it just like the free COVID-19 Bottom Line. But whenever we get to the new normal, we’ll still have some of the same health challenges; cardiovascular disease, diabetes, and cancer aren’t going away just because we have to self-isolate for a while.

A reader asked about a news article that showed eating and drinking citrus, specifically grapefruit, could increase the risk of getting melanoma, a severe form of skin cancer. A 2015 study based on the Healthcare Professionals Study and the Nurses Health Study showed a 36% increased risk of melanoma over 24 years when comparing those who consumed the most citrus with those who consumed very little. In doing the background research on the study, there were two other studies that demonstrated similar results.

Should we skip the glass of orange juice every day? What’s in citrus that could be a factor? I’ll answer those questions the rest of the week.

What are you prepared to do today?

        Dr. Chet

Reference: J Clin Oncol 33:2500-2508.

Natural ACE-Inhibitors

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Perhaps the thought crossed your mind that maybe you could get a prescription for an ACE-inhibitor. Maybe it was fleeting, just a wisp of a thought floating by, but it was there. Remember, a couple of studies do not a treatment make, and connecting dots doesn’t always end with the picture you think it might. We have no idea whether ACE-inhibitors will make any difference in dealing with the pneumonia from COVID-19.

Still, if there were something that we could do that might give us an edge from a natural source, wouldn’t that be a plus? It looks like some researchers have been examining that question for a long time; I read a review paper that provided some guidance.

Are ACE-Inhibitors Found in Nature?

Yes, is the short answer. The chemical structures of natural ACE-inhibitors vary, but they’re food peptides—short strings of amino acids, generally 2–50 amino acids long. When checking the BIOPEP Database, there were 891 peptide sequences that have been identified as having ACE-inhibitory traits.

The foods are diverse; they range from different types of fish such as sardines and Alaskan pollack, to chicken, eggs, beef, pork, and milk products. Vegetarian? No problem. Corn, wheat, soybeans, soy milk, garlic, chick peas, mushrooms, walnuts, and most likely, many more have the right properties.

Are All Natural ACE-inhibitors Biologically Active?

The ability of any peptide to work depends on its ability to survive the digestive system. Peptides can be broken down into their individual amino acids and may not reconstitute the sequence once absorbed. There’s limited research on extracts from foods and less on the foods themselves actually lowering BP.

We do have some research on whether a diet with these types of foods will lower hypertension; it’s called the DASH Diet. The foundation is whole grains, beans and legumes, lean proteins from meat, dairy, eggs, and fish. Together with reducing sodium and getting some exercise, the diet itself contains many naturally occurring ACE-inhibitory peptides. It may be that what lowers BP is the combined shift from a highly-processed, high-fat diet to the DASH Diet full of the right peptides.

The Bottom Line

Hypertension is one of the leading comorbidities for a severe case of COVID-19 if you get the virus. If you’ve been prescribed an ACE-inhibitor, I would recommend that you take it as directed. But it’s just as smart to add the foods with naturally occurring ACE-inhibitors in them. It may be that it’s what we’ve not been eating that’s putting us most at risk for a severe case of COVID-19.

What are you prepared to do today?

        Dr. Chet

Reference: doi: 10.1111/1541-4337.12051

Get This Free COVID-19 Audio

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The COVID-19 virus is impacting our lives, yet there seems to be a lot of confusion about what is and is not real. That’s why I’ve put together this free download on the COVID-19 virus. I’ve included the answers to questions I’ve gotten and divided them into a logical order. What is the history of the virus? Where did it come from? When will this be over? What do we do to protect ourselves? And finally, what are the myths surrounding the COVID-19?

This is the reference audio to use as baseline information. The numbers will certainly change; there will be new potential treatments; and there are certainly more myths being promoted every day. This audio is where to begin.

There are so many experts in all kinds of media right now, and you may wonder why you should listen to me. Here’s a link to my bio so you can see what my background is and decide for yourself.

What are you prepared to do today?

        Dr. Chet