Research Digest

Exclusive Sneak Peek

Issue 13, Vol 2of 2 ◆ November 2015

Click here to purchase ERD

Table of ContentsWhat are you feeding your bacteria?

While probiotics get most of the press, prebiotics arguably have more potential for alter-ing one’s microbiome. This study looks at a promising type of prebiotic supplement to see if it might impact appetite and inflammation.

Breakfast: A disempowering nutritional dogmaBy Martin MacDonald, Msc

Return of the globule: milk fat strikes backMilk fat is structurally different than most other fats, and the milk fat globule membrane has been looked at previously (twice in ERD, in fact) for its impact on chronic disease. But could it also impact response to exercise?

Not-so-safe supplementsStudies have shown that supplement buyers generally trust the supplements they buy. That might not be the safest assumption, as dietary supplements that are presumed helpful or neutral may sometimes cause serious side effects, as quantified by this study.

Probiotics and the propensity for portlinessWhen you eat a meal, your gut bacteria also eats a meal. And gut bacteria are increas-ingly looked at for their influence on chronic disease. This study looks at the effect of a specific probiotic blend on weight gain.

13

Breakfast:A disempowering nutritional dogma

By Martin Macdonald

Conflicts of interest: I currently eat breakfast but have, in the past, been known not to. I may also be biased by some amazing health transformations I have seen since my staff and I have started using breakfast skipping strat-egies as a personalized nutrition strategy in some clients.

Let me just set the scene a little. I am not saying that people shouldn’t eat breakfast; I’m saying that the fol-lowing nutritional dogmas need to die:

• You must eat breakfast• Eating anything in the morning is better than

nothing• Breakfast is the most important meal of the day• Skipping breakfast causes your body to go into

starvation mode• Skipping breakfast will make you fat• If you skip breakfast your blood sugar will go too

low• You must eat breakfast if you are exercising in the

morning

Disclaimer: I am guilty of previously saying 1 or more of these things. I’m just not afraid to admit it.

Breakfast in the context of this editorial is not ‘breaking the fast’; I will concede starvation is probably subop-timal compared to eating breakfast. There is no hard

and fast definition of breakfast but I haven’t found the need for an exact definition beyond ‘eating soon after waking’. The story of breakfast is a tale of government organisations, health associations, corporations, per-sonal experiences and mixed up science. There has never been a truer example of the saying “If you repeat something enough, it becomes truth.” than is the case with ‘breakfast is the most important meal of the day’. Seemingly, the message that breakfast is the most important meal of the day is almost innate; we all just ‘know’ it. If you don’t eat breakfast you really should lose some human rights or something …

I first started questioning the whole breakfast thing back in 2008 when for some reason, OK, I wanted bigger arms, I started messing about with meal timing around training. Until that point, as I have mentioned, I was a big believer, yes believer, that breakfast was extremely important. I say believer, as it is literally a matter of faith for most people, even health care profes-sionals (HCPs). They’ve never read the research or, a lot of the time, even been taught about its importance, they just know because a magazine/parent/the TV told them.

The process of setting public health messages has in part caused the breakfast issue, in my opinion. Cater for those who couldn’t care less about their health to try and stop them being as much of a burden on soci-

There has never been a truer example of the saying “If you repeat something enough, it becomes truth.” than is the case with ‘breakfast is the most important meal of the day.’

ety. One of the few benefits of junk cereals is that they are fortified with nutrients that an otherwise appalling diet may not contain. While it may be a difficult fact to swallow… a bowl of fortified junk cereal with milk is by definition more nutritious than another junk snack food with similar macronutrient levels. This is where breakfast really does have a strong hold and as I said, breakfast is better than starving so in the absence of anything else, I’m all for industry spon-sored breakfast clubs for low-income fam-ilies! However, the topics at hand are the dogmas I listed at the beginning of this piece. Will I really be more unhealthy if I skip breakfast? Should HCPs, espe-cially those paid with taxpayers’ money, really waste signif-icant time laboring the breakfast issue in health and weight loss clinics?

I once tried my hand at writing nutrition stories for kids: “You MUST eat breakfast!” bellowed the dietitian.” That’s as far as I got before the dietitian mafia mob shut me down. I didn’t need to use the word dietitian, it could have been nutritionist, weight loss group leader, personal trainer etc, but considering ‘dietitians’ are the only recognized nutrition professionals and supposed-ly ‘the gold standard’ for advice, I really feel they need to be held accountable. More so in light of some of the dubious connections the dietetic associations have with industry. It’s probably unnecessary for me to highlight just how ingrained the need for breakfast is but I will for the sake of completeness.

The NHS states: “Breakfast is an important part of being healthy. For a tasty and healthy start to the day, it’s good to base breakfast on starchy foods such as bread or breakfast cereals. Wash down breakfast with a glass of 100% fruit juice as this will count as a fruit and veg portion.” We get advice saying, “Don’t skip breakfast because otherwise you will snack throughout the day.” On the flip side we are told “it’s been shown eating

regularly during the day helps burn cal-ories at a faster rate.” Whilst this second point is completely incorrect, if it were true, it surely leaves us with some mixed messages! The British Dietetic Association (BDA), who are cur-rently sponsored by a processed, conve-nience breakfast bar, tell us:

“Carbohydrates kick start your metab-olism” as well as

mimicking the NHS party line of carbohydrates galore as the mainstay of breakfast. Here is one of their recom-mendations for a great breakfast:

• Bowl of fortified wholegrain cereal with skimmedmilk.

• Some tinned fruit in juice.• A small glass of fruit juice.• Currant bun

If I had an individual wanting to lose muscle whilst training for a marathon, I suppose it’s not far off a breakfast option I might give them. For the average person trying to maintain/improve their weight/health,

Almost universally, breakfast skipping leads to lower energy and carbohydrate intakes, two things that a lot of people eat too much of.

not so much. Finally, as you’d expect, NICE (the body that provides national guidance on health care in the UK) is a little better than the rest. It can’t be said that their guidance is incorrect, it is simply misleading and open to incorrect interpretation by those brainwashed to believe breakfast is the most important meal of the day. They recognise “that advice should be clear that breakfast may support a healthy weight if it is eaten as an alternative to energy dense snacks and overall daily energy intake is not increased.”

So what does the literature say about breakfast and energy intake? We know that correlations have been drawn between unhealthy people that don’t care about their health and skipping breakfast. We know skipping breakfast often increases hunger and decreases feelings of fullness, but I worry for people who need a study to tell them that. However, when we actually test this, what happens? It seems time and time again we see that skipping breakfast leads to a reduction in energy intake due to an incomplete compensation for the missed calories, with no reduction in metabolic rate. Almost universally, breakfast skipping leads to lower ener-gy and carbohydrate intakes, two things that a lot of people eat too much of. Of course breakfast cereal com-panies will use clever tactics in press releases to avoid this fact, such as “Skipping breakfast leads to overeating later in the day!” … despite the fact that overall energy intake is lower!

So why do we see the observations that we do? For a start, it simply isn’t possible to correct for a lifetime of non-health seeking behaviours. Compared with break-fast eaters, breakfast skippers time and time again have worse lifestyles. They smoke more, consume more alco-hol and sugar-sweetened beverages, and eat less fruit and vegetables. With all the new research on sleep and insulin sensitivity, the fact that breakfast skippers seem to go to bed later, might be another factor to consider. Let’s stop using observational data, shall we, and move onto the RCTs that are now available.

Time and time again in the breakfast research, conclu-sions are made that bare no resemblance to the findings of the study. I can’t work out if this is a lack of critical thinking or industry funding pressures. Even when 24-hour energy intake is measured and isn’t altered,we see recommendations for breakfast, ‘high energy’breakfast, high protein breakfast etc as a method forweight loss because it altered some insignificant mea-sure of appetite or energy intake at a single meal. Itseems a resounding conclusion that a recommendationto eat or skip breakfast for weight loss has no discern-able effect on weight loss in free-living adults who areattempting to lose weight. Again, perhaps highlight-ing the power of adherence. On this topic, I have beenguilty of using phrases like ‘we should find methodsthat give maximum benefits with the least disturbanceto an individual’s life’. I now view this as an area ofdeliberation with each client due to some research actu-ally showing that those who have to make the greatestchange to their usual habits lose the most weight. Is thisjust a factor of increased mindful eating? Even if this isthe case, add ‘mess with people’s timetables’ to your listof ‘tools for increasing mindful eating’!

Don’t kid yourself. The advice to eat breakfast, and the act of swapping from not eating breakfast, to eat-ing breakfast is not changing anyone’s health. Are the healthiest people healthy because they are adhering to guidelines to eat breakfast? Of course not. It is more than likely that if they are eating breakfast, it’s because they are active individuals who need to consume more calories (subconsciously driven by homeostatic mecha-nisms) to meet their needs.

To be pragmatic about the ‘giving advice’ side of things, getting someone to eat breakfast is an act of mindful-ness. If they adhere to your recommendation, they are likely to make other changes too, and the chances of some health improvement are high. If the morning is one major time that they can take time to eat a nutri-tious meal, and thereby changing that behavior actually

has a meaningful benefit, go for it! If guilt tripping them into eating something early means them reaching for breakfast biscuits and alike, instead of waiting until they could eat something more nutritious, you are fail-ing and so will they.

Lastly on this aspect it would be remiss of me not to mention the 6-week Bath Breakfast Study interven-tion that showed that body mass, adiposity, adipose tissue glucose uptake and CV indexes did not change between breakfast and breakfast skipping treatments. Interestingly though, they found that people moved around a bit more when they were given breakfast. An interesting insight perhaps into some homeostatic mechanisms at play in young healthy individuals?

The data behind increasing protein at breakfast leads me to think, if everyone could and would eat salmon and eggs in the morning, I’d happily get behind that

healthy eating message. However, that is not what is being encouraged, barring a few small fitness circles. Instead, we have the BDA saying that the ‘Meat, fish, eggs, beans and other non-dairy sources of protein’ food group is ‘non-essential’ with the recommendation ‘try not to have them every day.’ If you are in a hurry, they say, it’s important to have things you can grab. Like toast. So the message the public is getting is that it’s more important to eat a completely unbalanced meal, than nothing. The factsheet was written before they got into bed with the convenience food industry, so we can only imagine what the next update will contain …

So there you have it, this piece is not supposed to be used as evidence that breakfast skipping should be used as a preferred course of action. Instead, its aim is to stop dogmatic, mindless approaches to nutrition that reduce our ability to help as many people as possible, not just those who fit into a ‘box’. ◆

Martin is a Clinical Performance Nutritionist and CEO of Mac-Nutrition.com, the UK’s leading nutrition consultancy. He holds a BSc in Sport and Exercise Science and postgraduates in Sports Nutrition and Clinical Nutrition, along with the obligatory CSCS qualification.

Although he may not look like it, Martin does even lift; he actually competed as a natural bodybuilder in several shows spanning 5 years, before giving up and blaming his lack of success on genetics.

Previously a university lecturer and practitioner, Martin’s work is now predominantly as a consultant to organisations such as Universal Pictures, teams such as Derby County FC and Leicestershire CCC, and governing bodies such as British Weight Lifting and England Athletics. The rest of Martin’s time is either spent delivering seminars both nationally and internationally or spent working with a small number of exclusive clients between London, Dubai and Geneva.

Martin also co-hosts a podcast on iTunes, with an evidence-based dietitian, titled ‘Real Nutrition Radio’.

Not-so-safe supplements

Emergency Department Visits for Adverse Events Related to

Dietary Supplements

IntroductionDietary supplements are sometimes erroneously per-ceived as inherently healthy. And because of the way many supplements are advertised, it’s easy to overlook that improper administration can lead to adverse outcomes.

The classification of a supplement is defined in the United States Dietary Supplement Health and Education Act of 1994 (DSHEA) as a vitamin, miner-al, herb or botanical, amino acid, and any concentrate, metabolite, constituent, or extract of these substances. In the U.S., the Food and Drug Administration (FDA) is the governing body that oversees the regulation of dietary supplements. If a supplement has been report-ed to be causing serious adverse events or reactions, the FDA has the authority to pull it from the market. However, no safety testing or FDA approval is required before a company can market their supplement. The lack of oversight authority given to the FDA has even drawn the attention of late night talk shows hosts like John Oliver, who humorously covered the issue in this YouTube video.

Many adults are using one or more supplements to address illnesses or symptoms, and to maintain or improve health. Half of all U.S. adults have report-ed using at least one supplement in the past 30 days. Twelve percent of college students have reported taking five or more supplements a week. Now, more than ever, there are seemingly endless options to choose from. The number of supplement products currently avail-able on the market is thought to be in excess of 55,000. Compare that to the mere 4,000 available in 1994, when DSHEA was passed.

Furthermore, confidence in the safety and efficacy of these supplements is very high despite the lack of rigor-ous oversight by the FDA. A survey conducted by the trade association, Council for Responsible Nutrition, found that “85% of American adults … are confident in the safety, quality and effectiveness of dietary supple-

ments.” An independent survey has echoed these results, finding that 67.2% of respondents felt extremely or somewhat confident in supplement efficacy and 70.8% felt extremely or somewhat confident about their safety.

While the majority of Americans trust in their sup-plements, more than one-third have not told their physician about using them. There are numerous docu-mented drug-supplement interactions ranging from the mild to the severe. The herb St. John’s Wort is thought to be able to reduce symptoms in people with mild to moderate depression. But this ‘natural’ supplement also has 200 documented major drug interactions, including some with common depression medication. However, no good data currently exists to document how com-mon adverse events related to dietary supplements may be. The authors of the present study have used surveil-lance data to try and fill this knowledge gap.

Due to DSHEA, supplements remain largely unreg-ulated by the FDA. But dietary supplements are becoming ever more popular, as about half of U.S. adults report using one or more in the past 30 days. Trust in the safety and efficacy of these supplements also remains high. The authors of this study aimed to investigate how many annual adverse events are caused by improper supplement usage.

Who and what was studied?The researchers looked at 10 years of data (2004-2013) to estimate the adverse events associated with dietary sup-plements in the United States from 63 different hospitals. The selection of these hospitals was meant to be nation-ally representative and included locations that had 24-hour emergency departments. Trained patient recordabstractors reviewed the reports from each hospital toidentify cases where supplements had been implicatedas the likely source of the adverse event. These abstrac-tors have been trained to analyze and compile medicalinformation contained in patient records.

Cases were scanned for emergency room visits where the treating clinician had explicitly ascribed dietary supplements as the root cause of the medical issue. This included herbal or complementary nutritional products such as botanicals, microbial additives, and amino acids, in addition to micronutrients like vitamins and minerals. Products that may typically be classified as food were excluded, like energy drinks and herbal tea beverages. Topical herbal items and homeopathic products were included in the analysis even though they do not fall under the regulatory definition of dietary supplements.

Adverse events were classified as anything causing adverse or allergic reactions, excess doses, unsu-pervised ingestion by children, or other events like choking. Due to the non-standard death registration practices among different hospitals, cases involving a mortality were not included, as were any cases involv-

ing intentional self-harm, drug abuse, therapeutic failures, nonadherence, and withdrawal.

Researchers examined patient records from 2004 to 2013 from 63 different hospitals. Cases where the treating clinician had identified a supplement as the cause of the medical emergency were extracted from the dataset. However, deaths associated with or caused by supplements were not included, as hospi-tals differ in their practice of registering mortalities.

What were the findings?Some of the major findings are summarized in Figure 1. Over 3,600 cases were identified within the prede-termined 10-year period. The researchers extrapolatedfrom these data that the U.S. experienced an average

Figure 1: Supplement safety by the numbers

of 23,000 supplement-related emergency department visits per year, with estimates ranging from 18,600 to 27,400. Of these 23,000 emergency room visits, it was calculated that about 2,150 (9.4%) of these result in hospitalization. About 88% of these ER visits were attributed to a single supplement, as opposed to inter-actions or mixtures of multiple supplements. The average age of patients treated for supplement-related adverse events was 32 years, and the majority of these cases were female.

Figure 2 shows age and supplement category related results. About a quarter of ER visits involved people between the ages of 20 to 34, but people older than 65 years old were more likely to have a visit that resulted in hospitalization. Of patients above 65 admitted to the ER, 16% had to be hospitalized. Surprisingly, one-fifth of supplement-related ER visits were due to accidental ingestion by children. When the data covering unsuper-vised ingestion of dietary supplements by children was not included, the researchers found that the majority

of ER visits (65.9%) were due to herbal or complemen-tary nutritional products. The top five products in this category included the following: weight loss (25.5%), energy (10.0%), sexual enhancement (3.4%), cardiovas-cular health (3.1%), and sleep, sedation, or anxiolysis (i.e. anti-anxiety) (2.9%). Multivitamins or unspecified vitamin products were the biggest contributors to ER visits under the micronutrient product category.

ER visits also varied according to gender and age. Weight loss and micronutrient supplements dispro-portionately landed females in the ER, while sexual enhancement and bodybuilding products largely affect-ed males. Among patients younger than four years old and adults over 65, micronutrients were the number one cause of emergency department visits. This is in contrast to the other age groups, where herbal and complementary nutritional products were the biggest contributor. In people ages five to 34, weight loss prod-ucts or energy products were implicated in more than 50% of ER visits. Weight loss products mostly affected

Figure 2: Summary of which types of supplements lead to ER visits by age

Source: Geller AI et al. N Engl J Med. 2015 Oct.

patients from 20 to 34 years of age, while the micro-nutrients iron, calcium, and potassium mostly affected those older than 65.

About 23,000 people go to the ER for supplement-re-lated visits every year. The biggest contributors to this are herbal or complementary nutritional prod-ucts like weight loss and energy supplements, which largely affect people between the ages of five to 34. Females are more likely than males to end up in the ER due to adverse supplement reactions. Those over the age of 65 are most at risk for an ER visit due to micronutrient supplements such as iron, calcium, and potassium.

What does the study really tell us?While 23,000 annual supplement-related emergency vis-its may sound high, this is less than 5% of pharmaceutical product-related ER visits. However, these ER admittance rates do not line up with the marketing that has promot-

ed dietary supplements as fundamentally healthy. That is, the general public overwhelmingly perceives these prod-ucts to be safe and effective, but the present data does not support this notion (ERD readers excluded. We think you are all ahead of the curve on this one).

However, it should also be noted that overall incidences of supplement-related ER visits have remained con-stant over time. No significant changes were detected between 2004 and 2013 when accounting for popu-lation increases. The only increase that occurred was ER visits associated with micronutrient supplements, which jumped 42.5%, from 3,212 to 4,578 cases in this same time frame.

Unlike their highly regulated pharmaceutical coun-terparts, there are no legal requirements for dietary supplements to identify any potential adverse effects or major drug interactions on their packaging. The lack of adequate warning labels may be a contributing factor to why histories of dietary supplement usage are rarely obtained by clinicians. This can be due to a combina-tion of clinicians not asking proper patient screening questions and to a lack of disclosure by the patient.

Proprietary Blends

The FDA has established labeling standards dictating what must appear on a supplement’s packaging. Manufacturers must list out each ingredient, and are required to display the amount or percentage of daily value of those ingredients.

A proprietary blend falls under a slightly different set of regulations. Blends are a unique mix-ture of ingredients that are typically developed by the manufacturer. The FDA requires that all ingredients of a proprietary blend be listed on the label in descending order according to pre-dominance of weight. While the amount of the blend as a whole must be listed, the amount of each ingredient included in the blend does not.

Blends are used to help prevent the competition from knowing what the specific formulation is. But it can also hide the fact that very little of an active ingredient may be in the bottle. So while a proven performance enhancing ingredient like creatine may be listed in a proprietary blend, it could be well below what is considered to be an effective dose.

Given that there is a tendency to underreport sup-plement usage, the researchers have noted that their calculations of emergency department visits attributed to supplement-related adverse events are probably an underestimation. A further limitation was the relative-ly small sample of hospitals used. But this method of data collection is likely to yield more accurate results over voluntary reporting despite the fact that volun-tary reporting would have likely allowed for a larger sample population.

While 23,000 annual supplement-related emer-gency visits may not be a large contributor to ER visits in the larger scheme of things, it does provide a counter-narrative to the marketing that often portrays supplements as always health promot-ing. Supplements are not required to come with labels warning of adverse events or potential drug interactions, which can be a contributing factor to supplement-related ER visits.

The big pictureThe supplement industry is the wild west of nutrition. By and large, DSHEA has hampered the ability of the FDA to adequately regulate supplements. If you have ever taken a supplement that makes a health claim, you may have encountered this statement on the label: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” While all ingredients must be declared on the label, there is lit-tle oversight to ensure that these ingredients are present in the supplement, at the doses that are advertised on the packaging. Under DSHEA, there is no requirement for companies to provide any data to the FDA showing that their supplement is safe and effective, unless they are introducing a new or novel ingredient. It falls on the FDA to show that a supplement is unsafe before any action can be taken.

In light of this lack of regulatory oversight, if you are currently taking or thinking about adding a supplement to your diet, be sure to notify your doctor. Supplements can interact with prescription medication or could exacerbate certain medical conditions. Warfarin (Coumadin) is a good example. It is a blood-thinning medication that can be prescribed to people at risk of forming blood clots. To ensure that the medication works properly, these patients are usually placed on a low vitamin K diet, as vitamin K plays an essential role in forming blood clots. If these patients do not disclose that they are taking a multivitamin with vitamin K, multivitamins being one of the most commonly used supplements, they could be putting themselves at risk for developing unwanted clots.

Currently, the supplement industry is partially policed by itself. Companies that market and sell supplement products do not have to show the FDA data of safety or efficacy in the same fashion that pharmaceutical companies do. The FDA can step in when a supplement has been shown to cause harm and pull it from the market. It is important to dis-cuss all supplements you may be taking with your doctor to avoid unpleasant or dangerous interactions. Be sure to tell them even if they do not ask during your screening.

Frequently asked questionsIs there any way to ensure that I’m purchasing a quality supplement?? There are companies out there that do supply third-par-ty certifications to supplement manufacturers. These companies will verify that the supplements listed on the ingredient list are present in the concentrations claimed. There are four major companies that provide these certifications, which are shown in Figure 3: NSF International, Informed Choice, Consumer Lab, and U.S. Pharmacopeia. With the exception of Consumer

Lab, all of these third-party certifiers print their seal on the products they have screened.

The testing process often involves looking at the puri-ty, strength, and bioavailability of the product. Good manufacturing practices, which help to provide systems that track proper design, monitoring, and control of the manufacturing process and facilities, are also frequently taken into account. Many employ continuous random testing in order for a given supplement to remain cer-tified. It is very important to note that these companies do not test for efficacy. That is to say, these certifications do not ensure that any health claims made about the supplement are truthful.

What should I know?While 23,000 dietary-supplement related ER visits may not seem like a lot when compared to something like the 610,000 deaths caused by heart disease every year in the U.S., it is something that can be easily prevented with education and awareness. Although supplement

related deaths were not included in the ER visit pro-jection, which could lead to an underestimation, it is also possible that emergency department physicians may have incorrectly ascribed certain signs and symp-toms to supplements, which could consequently lead to overestimation. Essentially, the 23,000 annual ER visits should be viewed as a very rough estimation.

If you are currently taking or planning to introduce a supplement to your diet, be sure that you are con-suming the recommended dose for that product and consult your doctor before hand. Supplements are not automatically beneficial for health, no matter what the marketing says. Treat dietary supplements the way you would treat medication, with caution and respect for

their ability to both help and harm your health. ◆

An incredibly effective supplement may also be incred-ibly harmful given the right (well … wrong) context. Talk about the under-discussed issue of supplement safety at the ERD Facebook forum.

Figure 3: Third-party supplement certifications