Wednesday, May 14, 2014

Can An OTC Supplement Quadruple Your Weight Loss Success? Recent Study Says: Yes It Can! But The Absolute Improvements in Body Composition Are Still Pathetic

I am sorry, but I have to tell you: Significant weight loss does not happen without effort. Even if you take a pill that comes with just this promise.
I guess you will not have heard about "IQP-GC-101", before - right? Well, me neither, but it is obviously a patented blend of a bunch of very familiar weight loss adjuvants, namely Garcinia cambogia, Camellia sinensis, unroasted Coffea arabica (aka green coffee bean extract), and Lagerstroemia speciosa. All of them were pressed into tablets, the scientists from InQpharm, the producer and patent owner handed to 92 German subjects who had volunteered to participate in a double-blinded randomized study in the course of which they had to (a) adhere to a -500kcal/day energy deficit and (b) consume three tablets of either IQP-GC-101 or an identically looking placebo twice a day - once 30min before breakfast and once 30 minutes before lunch.
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Now, it goes without saying that this is not the first sponsored weight loss study. So you may be asking yourselves rightly, why this one made it into the SuppVersity news while most of the other trash did not, right?  Well, there are actually a handful of reasons, of which I consider the following two to be most significant:
  • The study design: Double-blinded, an impressive number of subjects (n=91; one subject was "lost to follow up after randomization"; Chong. 2014), all caucasian with a mean age of 42.8 ± 11.2 years (31.9% were male), and full details on the ingredients of the supplement - that's nothing you will see with the average "pimp my product" study
  • The supplement ingredients: Garcinia cambogia aka HCA, camelia sinensis aka green tea, coffea arabica aka green coffee bean extract and lagerstroemia speciosa aka Banaba are all ingredients you will find in many of the currently available supplements.
I guess, I could add that interesting supplement news are slow, these days and that I am so freaking busy that I had to pick the next best study from my "could be something to write about in the future" folder, but I am not sure how relevant that would be ;-)

Apropos "relevant", what certainly is relevant is the ingredient profile each of the 6 tablets (2x3) the subjects consumed on a daily basis:
  • Table 1: Subjects' demographics at baseline - age (years), height (cm), body weight (kg; from Chong. 2014)
    G.cambogiaextract (650 mg) – standardized to at least 60% HCA; 
  • C.sinensis extract (100 mg) – at least 15% epigallocatechin-3-gallate and 11% caffeine;
  • unroasted C.arabica extract (75 mg) – at least 25% chlorogenic acid and 5% caffeine; and 
  • L. speciosa extract (25 mg) – at least 5% corosolic acid in a standardized extract
The "at least..." indicates that the producer guarantees a certain level of active ingredients. That's the case for most of the reputable companies, but in view of the fact that there are more than enough snake oil vendors out there, I think it may be prudent to repeat my advice: Whenever you look at the ingredient level make sure the producer declares the level of active ingredients.
Do not buy non-standardized herbal / natural supplements! You could not only be wasting your money on products without active ingredients, you could - in the worst case - end up with a sloppily produced extract that contains all the bad stuff from the raw material (e.g. all the heavy metals from Chinese green tea | learn more) and not a single microgram of the of the active ingredient.
You don't want "green tea" in your fat burner, you want a green tea extract with a standardized amount of catechins in it and if the bottle doesn't say anything about "standardization" / "standardized for", etc. you can be sure that what you are buying is hardly different from the content of the contents of the cheapest tea bags from the supermarket next door - the only difference being: It did not have to pass the rigorous quality control of the supermarket chain!

But let's get back to the study at hand. The subjects consumed what I would call a pretty lame iteration of the SGD, the "standard German diet". It's not as "SAD" as the standard American one, but my fellow countrymen and -women have gained some ground in terms of eating unhealthy over the past two decades; and the fact that "[t]he diet plans were compiled by a dietician and ensured a balanced diet providing 30% of the ingested energy as fat," (Chong. 2014) does not increase my confidence in the overall quality of the foods the subjects consumed at one out of five distinct energy equivalents, i.e. 1500, 1800, 2000, 2200, and 2500 kcal per day - obviously calculated based on the theoretical energy requirements of the subjects.
The kcal-display lies to her!
SuppVersity Suggested Reads: "Predictive Value of Equations to Calculate Your Resting Metabolic Rate (RMR) Flawed: Results Can Be 14-29% Off" | read more - At this point I would like to invite you to take a look at the real-world validity and the corresponding "value" of calculated energy requirements. In the corresponding article, as well as in a more detailed follow up that includes 9 Tips to Optimize Fat Loss and successfully manage your weight, I outline a couple of commonly known but often overlooked principles that facilitate real and lasting fat, not weight loss.
If we rely on the messed up 3,500kcal per pound of fat calculation I've debunked years ago (read the corresponding article "Busting the 3,500kcal = 1lbs Weight Loss Myth!"),  the "diet" alone should have yielded a net reduction in body fat of ~1lbs per week and thus a total fat loss of 12weeks x 1lbs per week = 12lbs or ~6kg of pure fat!

I hope you are not surprised to see that this was exactly not what happened. In fact, after the first four weeks, when the subjects in both groups should have had lost roughly 2kg of body fat, the average study participants in the active and the placebo arm of the study had lost only ~1lbs of body fat and a total of ~1.5lbs of weight.
Figure 1: Absolute changes in body weight (kg) and body fat (kg) over the 12-week study period (Chong. 2014)
Now, in all fairness, it should be said that the 4-week margin was actually the 2-week margin for the active treatment. There was a 2-week run-in, after which 10 non-compliant subjects were removed and the rest of the subjects were randomized to receive either the placebo or active treatment. Against that background, it makes sense to isolate the body weight and body fat trajectory from week 2 to week 12 ... et voilá! The result does already look much more promising. Still, in spite of the fact that the subjects in the active arm lost almost 4x more body fat, the overall result, i.e. -1.21kg of fat over 12 weeks in overweight subjects, is still pretty pathetic.

Programming a 500kcal deficit based on calculated energy expenditure is stupid

Moreover, the fact that the subjects in the placebo arm gained almost 1lbs of body fat does not speak to either, the competence of the "registered dieticians" who compiled their diets, or the subjects' ability to stick to their alleged 500kcal deficit.

2x-3x higher than RDA protein help men and women lose fat, not weight, but there is a limit to wheer more is actually better | learn more
If you have not read it, already, this would be a good time to read my previous article on the "validity" *rofl* of the currently available equations to calculate your energy requirements (read more). And remember, while I personally don't believe that there is such a thing as diet induced "metabolic damage", it's a scientifically validated matter of fact that there are normal-, hyper- and hypometabolizers. And people with a mean BMI of 28+kg/m² (see Table 1) who belong to the sedentary average of the German society and are thus not just by definition "overweight" are probably more likely to be hypo- than normal- let alone hypermetabolizers.

This means, compared to the average for whom the equations the dietitians used to calculate their baseline intake may be more or less accurate, their real energy expenditure would be lower than what the equation says.

It's thus not impossible that their weight and fat gain (see Figure 1) was a simple result of the dieticians' stoic over-reliance on unreliable math and a minimal real-world calorie deficit (probably way below 500kcal) that was further reduced by non-adherence - especially in the placebo group.
Is garcinia or hydroxycitric acid aka HCA even safe? Ever since the FDA report about Hydroxycut(TM) (FDA. 2013). Most people think garcina was not safe. If you look at the evidence, it's yet not as "black" as the FDA has painted it in their warning against Hydroxicut(TM). If you look at some of the latest studies, you will even find conclusions such as the following statement from a well-referenced letter to the editor of the World Journal of Gastroenterology:
"In both animal and clinical literature, elevated intakes of HCA per se have not led to signs of inflammation or hepatotoxicity. The compound has been found to reduce markers of inflammation in brain, intestines, kidney and serum."(Clouatre. 2013) 
In the study at hand, the researchers did likewise not observe any liver problems or similar allegedly HCA-related side effects. In view of the rather mediocre results, the safety question may yet be more or less irrelevant, anyway.
 Bottom line: Specifically in view of the last remarks on dietary adherence, the significant inter-group differences speaks in favor of the the use of the patented weight loss formula in an average Joe's messed up diet scenario with a focus on food and macronutrient quantities, instead of qualities, a low protein intake (learn more about 2xRDA protein intakes, while you're dieting | here) and no exercise component, which would steer the total weight loss away from lean and towards fat mass.

On the other hand, the absolute amount of fat the subjects lost even when they were using the "fat burner" was pathetic. Any appetite suppressing or fat burning effects the formula may have are thus not pronounced enough to produce meaningful, or at least statistically significant weight, let alone fat loss. With standard deviations of 1.84 kg and thus 150% of the statistically mean in the active arm of the study, there were more than enough subjects who gained body fat in spite of the fact that they (supposedly) consumed less energy than they needed and were taking a patented weight loss adjuvant. A weight loss adjuvant with "proven" ingredients.... or should I say, with ingredients for which you can cherry pick evidence that they may increase fatty acid oxidation, inhibit lipid synthesis, decrease inflammation, increase insulin sensitivity and reduce food intake - in many cases even in human studies (see References). The fact that this does not necessarily mean that you will experience significant and visible fat loss effects, is thus probably the actual bottom line to the study at hand; and that's a bottom line that's valid irrespective of all declared conflicts of interest.
Reference:
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  • Chong, P. W., Beah, Z. M., Grube, B., & Riede, L. (2014). IQP‐GC‐101 Reduces Body Weight and Body Fat Mass: A Randomized, Double‐Blind, Placebo‐Controlled Study. Phytotherapy Research
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