Tuesday, July 28, 2009

More on Exercise without Diet doesn't produce Weight Loss and the Ethics of Research

Despite the promising title, Eight weeks of resistance training can significantly alter body composition in children who are overweight or obese, the results don't offer what one might expect from it.

Most of us would say "body comp" means weight, girth measures, bmi changes. But no. It doesn't. In this case, it seems to mean fat kids who worked out got stronger, added lean mass, but didn't lose weight or overall fat. This is consistent with other studies of working out without diet to go with it:

McGuigan, MR, Tatasciore, M, Newton, RU, and Pettigrew, S. Eight weeks of resistance training can significantly alter body composition in children who are overweight or obese. J Strength Cond Res 23(1): 80-85, 2009-

The purpose of this study was to investigate the effect of an 8-week resistance training program on children who were overweight or obese. Forty-eight children (n = 26 girls and 22 boys; mean age = 9.7 years) participated in an 8-week undulating periodized resistance training program for 3 d[middle dot]wk-1. Measures of body composition via dual-energy X-ray absorptiometry, anthropometry, strength, and power were made before and after the training intervention. There was a significant decrease in absolute percent body fat of 2.6% (p = 0.003) and a significant increase in lean body mass of 5.3% (p = 0.07). There were no significant changes in height, weight, body mass index, total fat mass, or bone mineral content. There were significant increases in 1-repetition maximum squat (74%), number of push-ups (85%), countermovement jump height (8%), static jump height (4%), and power (16%). These results demonstrate that the resistance training program implemented produces significant changes in body composition and strength and power measures, as well as being well tolerated by the participants. An undulating periodized program provides variation and significantly increases lean body mass, decreases percent body fat, and increases strength and power in children who are overweight and obese.
Update: as R.M. Koske rightly points out in the comments below, body comp is technically changes in fat/muscle/bone ratios. And it's not entirely fair to conflate a scientific definition of a concept used in a research journal with popular understanding. But i DO take issue with the term SIGNIFICANT body comp alteration. more on that below.

First off, the main goal of the study was to explore resistance training rather than aerobic intervals training for obese kids. As far as i can tell, they are simply hypothesizing that some kids who are obese may prefer lifting to running type activities, and if that's the case, let's see what that does. That's not much of an hypothesis to test in a research environment is it?


Not surprisingly, since other research has shown this too, obese kids in an 8 week program make super strength and power gains too. Just like non-obese kids. And like adults of all ages who are new to lifting. Neural adaptations are taking place, and new tissue is being laid down.


Now the authors claim that their findings are great. They say

An undulating periodized program provides variation and results in significant increases in lean body mass, decreased percent body fat, and increased strength and power.

It's really great to see BMC going up too - that's something to keep for life.
But where does this take us? IF absolute fat doesn't go down, weight goes up, how does bf% go down? There's more new lean mass. as opposed to more (or less) fat. That's kinda fudging, isn't it?

These results (gaining lean mass; not losing weight overall) are consistent with both non-obese kids and adults. It tells us that muscle building mechanisms for the first 8 weeks of a program have an impact. That's good. What about the next 8 weeks and then the next 48 weeks?

When we work with adults who are overweight, we know that after 8-12 weeks, if their girth, weight, and fat - nothing on these measures seems to change - they are not feeling a whole lot of love and success or seeing it in their mirrors.

We know that the study reports here that eating habits didn't change throughout the study. They weren't logged too religiously, though, and unless an observer is making those logs, we know from other work that we ALL misreport food logs.

We know that folks may feel zippier from working out - and that's fabulous - but we also know with obese adults that without nutrition, all the jumping and pumping in the world will not shed the excess weight which is having the biggest negative impact on overall health.

What's the Point? In fairness, one might say, this study was *just* looking at effects of resistance training over 8weeks on obese kids. Is that good enough? These are real kids with real problems. Is this fair to them or the best we can do?

Consider this: the study doesn't explicitly state an hypothesis, eg: we postulate that fat kids who do resistance will have the same benefits as non-fat kids who start resistance.

Hypothesis Testing
Is that poor science not to have an explicit hypothesis? Generally speaking, in most fields, yes.

Because you have to defend why you hypothesize your position and show value of the study: why on earth would you think you'd need to see if fat kids respond to resistance training differently than skinny kids? When that's said outloud, kinda makes one go "hmm" no?

Without that rationale for the study being clear, what's the point of the work? It's rather gratuitous. The authors as said only suggest that some fat kids might not like aerobics or intervals so they need alternatives. Right! so the next point would be again to say, we have lots of results to show the benefits of resistance training for kids. What's the special thing you think you need to test in this population not covered by these other studies?

Well, these kids are obese.
Ok, so what? are you asserting that because of that, the effects of a resistance program may be different? if so why? what's the basis for that assertion and how will you test it? Are there special fat kid risk factors to test that one might think fat kids shouldn't do resistance? No? So what's the point?

The authors just show what we already know from a zillion ways past sunday: resistance training builds lean muscle. And even if absolute fat doesn't go down, because lean muscle goes up, the bf% ratio changes. And as we see in the charts, kids did gain weight - from the lean muscle.

That's why these kind of studies seem gratuitous to me. And heh, not every paper an academic writes is earth shattering. But something leaves me edgy here. Obesity is a real problem. This study is dealing with clinically overweight and obese kids (over 23-43% body fat in the study).

So we've confirmed that yet one more population benefits from resistance training. Was there any doubt, however, that that would be the case? Any hypothesis to test? No? then what's the study contributed, really? For 8 weeks kids got no nutritional counseling when the authors KNOW that obesity programs combine nutrition and exercise. "
It is clear that, along with nutrition and lifestyle, exercise plays a significant role in overcoming obesity in children."

But if the authors had provided that counseling, that would have screwed up their results: they wouldn't know what was down to resistance vs what was down to diet.

Now ethically, we can say the children weren't harmed; in fact they are healthier than when they started. And still obese. And if they stick with their current training and their current activity they'll still be obese a year from now.

What's actually been proven here? hypothesis testing two. In the realm of statistics, one can simply set an alpha or confidence level - a percentage - by which if the results fall within that percentage, the results happened because of the intervention, not by chance. The way the authors set up this study, their signficance values don't claim that the body comp change is significant, but that the reason for the change is down to the intervention. That's right. Just that what change occurred is not because of chance but because of the progam. In other words they have an above 95% certainty that that body comp change is because of the training. Shocking.

Ok, that's not shocking but it means the title is:
Eight weeks of resistance training can significantly alter body composition in children who are overweight or obese. All that can be claimed, surely, is that we know within the realm of probability, literally, that resistance training has an effect at changing body comp. To say a "significant" effect - again means kinda weasel words. In stats, significance just means there's a treatment effect. To normal human beings significant means "wow that was a big deal."

So the authors are being technically accurate, but less clear that perhaps saying "Resistance training does induce body comp changes in fat kids in 8 week protocol, really really"

So, bottom line, did we learn anything new from this study that we didn't know before? Are the results surprising in any way? Was a bold hypothesis demonstrated? Did researchers who know that nutrition and lifestyle along with exercise is a big part of dealing with obesity provide that information to their participants' families as part of the study or just say good bye to the participants at the end of the 8-weeks?

If you're in an arm cast consider creatine to keep up your muscle

Here's a very simple find that seems intriguing. Say your arm is in a cast and you can't work out. The old saw in muscle work is use it or lose it.

Turns out, at least for young men who haven't done creatine before, that doing *some* creatine supplementation makes a difference in terms of preserving lean tissue in the upper limbs.


Johnston, APW, Burke, DG, MacNeil, LG, and Candow, DG. Effect of creatine supplementation during cast-induced immobilization on the preservation of muscle mass, strength, and endurance. J Strength Cond Res 23(1): 116-120, 2009-

Muscle and strength loss will occur during periods of physical inactivity and immobilization. Creatine supplementation may have a favorable effect on muscle mass and strength independently of exercise. The purpose of this study was to determine the effects of creatine supplementation on upper-limb muscle mass and muscle performance after immobilization. Before the study, creatine-naive men (n = 7; 18-25 years) were assessed for lean tissue mass (dual-energy X-ray absorptiometry), strength (1-repetition maximum [1RM] isometric single arm elbow flexion/extension), and muscle endurance (maximum number of single-arm isokinetic elbow flexion/extension repetitions at 60% 1RM). After baseline measures, subjects had their dominant or nondominant (random assignment) upper limb immobilized (long arm plaster cast) at 90[degrees] elbow flexion. Using a single-blind crossover design, subjects received placebo (maltodextrin; 4 x 5 g[middle dot]d-1) during days 1-7 and creatine (4 x 5 g[middle dot]d-1) during days 15-21. The cast was removed during days 8-14 and 22-29. The dependent measures of lean tissue mass, strength, and endurance were assessed at baseline, postcast, and after the study. During immobilization, compared with isocaloric placebo, creatine supplementation better maintained lean tissue mass (Cr +0.9% vs. PLA -3.7%, p


The authors caution that results by others of testing lower limb immobilization has not found these results. They wonder if it's the ratio of fiber types in the upper limbs or other factors that show these results. Suffice it to say, if you find yourself in an arm cast, you may want to consider trying some creatine to reduce "
myoplastic changes directly related to disuse atrophy, thereby facilitating the rehabilitation process."

Just be sure to get a good quality creatine :)

Monday, July 27, 2009

Rannoch's 100s (R100s): the unWorkout that Refreshes, repairs and prepares the embodied soul for work

Rannoch Donald of Simple Strength, RKC extra-ordinaire of Scotland, and one of the top most rated RKC instructors has a simple philosophy about basic training. Well, really he's got a lot of philosophies, but i like this one in particular.

300 is so 2007. 100 is where it's at.
Awhile ago Rannoch was telling me about his philosophy of getting 100 reps in a day of something. Doesn't matter what. Just get 'em in.

Now at the time i thought that was way cool, and as i have a variety of kettlebells around me at work and home, i started doing 100's of light snatches. That sorta faded from my view for awhile traveling, but in terms of coming back to some serious preparatory training, and feeling kinda down on myself for being deconditioned, i thought about Rannoch's 100's and thought well at least i can start there.

This was a new way of thinking about using the 100's as pump priming.
So i got a 100 out of the way with one weight.
And i felt better.
That was something when i didn't think i was going to have time then for anything.
That's a start; that's a foundation.
That's a few minutes of work i wouldn't have had before a morning shower.

So after a cup of tea, i did another 100. heavier. harder. stinkier

Aside: The pause that refreshes (when the unpause is stupid). When my hand was feeling a little raw on the bell i did something i usually don't let myself do: i put the bell down for a sec and did not feel like a failure or loser for taking a break 25 reps in to go find the chalk. I chalked. And continued. Who said it had to be non-stop every time? Maybe tomorrow it will be. Today i needed chalk - and am i glad i did or there would not be a tomorrow. (I put the ability to take a break down to intense work on getting rid of crap around goals -but that's another story)

So i got in two blocks of non-threatening-to-my-cns-first-thing-in-the-am, happy R100's before the morning shower. First one, gentle reminder with some effort in endurance; the second one more work overall. Good.

Threat Modulation value of 100's
One might say well hell that's not working out, that's not serious. that's nothing.

Well it sure as heck is greasing the neurological groove. Reminding my body about the time it takes to get in 100 consecutive perfect snatches; looking to keep that under 5 mins. Letting my body know what it feels like to find the flow of that movement. Then taking it up a notch. Still feeling safe. Letting myself get chalk to protect my hands - and so feeling safe and those reps were better. And getting in volume on a move. The perfect rep is still the perfect rep.

Those 100s then have great psychological benefit, and what's really cool, considerable neurological benefit, to let my brain, the body and their connective cns tissue work together well and get ready for the Great Work to Come.

Preparation vs A Plan of Action: 100's as the unpsych psych
As said, i'm getting ready to do some serious training. Talking about "getting ready to do some serious training" is a rather newish concept for me anything outside seasonal macro cycles for Strength and Conditioning athletes for pre during and post season training.

What i'm talking about with Preparation is the prep to get into the training i know i need to do for a particular training goal that has a specific date attached to it. What i've learned in the nutrition context and work in the habit-changing context is that when we're introducing a new behaviour (and new can be relative) we often fail because we leap into action without having a plan of how we'll deal with stuff around the action.

For me right now i know that if i try to leap into a heavy training regime some part of me will balk: i need to revise my wake up times and all the rest of it.

So Rannoch's 100's around all the moves i'll need to practice are great ways for me to prepare for the work to come; to get the conversation with my brain and body happening to make the coming 6 months effective, injury free and why not fun?

Non Excercise Physical Activity is Good Too. If you don't need R100's for your prep, that's cool. You may want to consider them as a little extra daily grit like the value of NEPA's. They're great for that too. just super in fact.

What are R100's then?
Rannoch's exact definition may be different, but my sense of them is as something pretty low threat, easy to focus on form, with some at least NEPA value to them.

Likely 100 consecutive whatevers is the goal.

If it's so intense as to require (a) breaks for recovery mid 100's or (b) a do or die requirement for a shower after said 100 cuz you stink beyond what's fit for polite company - it may just be too intense for what we're describing.

Now my second set of 100's today did not pass that later shower requirement test. Do i care? no. i wanted to get some effortfulness in. And the first R100 made that happen. ya hoo.

Hope you'll give some r100's a go - especially if you're a little freaked out about getting into an intense workout regime or if you can't think of where you'll get your workout in today. What's 100 of something you know you can do?

3 minutes of icing to let you play again? Really?

Would you be surprised to learn that if you apply an icebag to your hamstrings for ten minutes, and then go to do a vertical jump, you'll jump less high than if you didn't have an icebag on your leg for ten minutes? Ah but what about 3mins of icing? and why should you care about the difference? Consider this recent article in the Journal of Strength and Conditioning Research:

Functional Performance Following an Ice Bag Application to the Hamstrings

The Journal of Strength & Conditioning Research. 23(1):44-50, January 2009.

doi: 10.1519/JSC.0b013e3181839e97

This study examined the immediate and short-term (20 minute) effects of 3- and 10-minute ice bag applications to the hamstrings on functional performance as measured by the cocontraction test, shuttle run, and single-leg vertical jump. Forty-two (25 women, 17 men) recreational or collegiate athletes who were free of injury in the lower extremity 6 months before testing and who did not suffer from allergy to cryotherapy were included. Time to completion was measured in seconds for the cocontraction and the shuttle run test. Single-leg vertical jump was measured on the Vertec (Sports Imports, Columbus, Ohio) in centimeters. The 10-minute ice bag application reduced immediate postapplication vertical jump performance and increased immediate post and 20-minute post shuttle run time (p <= 0.05). A decrease in cocontraction time was observed at 20 minutes post compared with preapplication during the control condition in which no ice bag was applied. Power and functional performance are affected by short-term cryotherapy application. Power and functional performance was impaired immediately and 20 minutes after 10-minute ice bag application to the hamstrings, whereas a shorter duration of ice application had no effect on these tasks.

Right. Really, this result can't be seen as much of a surprise, so why did this study get published - publication of work generally means there's deemed to be a "significant contribution" to the field by the work presented

This is a little better unpacked in the article. Icing is used a lot for dealing with injuries. It's one of the famous parts in RICE, rest, ice, compression and elevation.

Aside: why ice? Turns out that RICE is being debated. While lots of good things have been claimed about icing, and there's literature that says, even though we don't know why, icing works better with compression, (er, maybe it's just the compression) some folks have been wondering if compression and ice are really great ideas rather than not interfering with the body's natural injury healing mechanisms. What about heat instead? what about no restriction on the area? what about compression rather than cold? what about letting the body just do it's thing?

A recent summary in 2007 by JL McDonald called Fire and Ice (pdf) states:
When the evidence to support the use of ice in musculoskeletal disorders is separated out from the commonly used context of the RICE (Rest, Ice, Compression, Elevation) protocol, it has been claimed that ice alone is effective in relieving pain, reducing oedema and relieving muscle spasm.

• The evidence suggests that ice alone has a local anaesthetic [cuts off sensation -mc] rather than analgesic effect [actually acts on pain signals -mc].
• There is contradictory evidence for whether or not ice alone can reduce oedema [tissue swelling - mc] , but it may be that compression is the most effective component of the RICE protocol for oedema, given that, while compression is effective in reducing oedema, the addition of ice to compression shows no additional benefit.
• No evidence was found in the reviewed literature to support the assertion that ice can relieve muscle spasm, although there is consensus in the research that local heat can.
I mean, folks make it sound so obvious: use ice (and elevation and compression) to bring down swelling, not heat because
Heat is not your friend at first, because it increases circulation, which puts painful pressure on nerve endings. The warmth stimulates the flow of inflammatory chemicals, too, which make pain worse.
Ok, pain is not necessarily a good thing, but if stimulating the flow of inflammatory chemicals is bad (is it? isn't inflammation an essential first part of healing? but ok, more is not always better) - what's the deal with trying to cut off that process with ice? what's ice doing in this kind of tissue condition where only ice is used? It doesn't bring down swelling - that's compression, apparently; it doesn't mitigate pain chemistry; it doesn't calm down spasaming muscles. What's left is that it anesthetizes the pain response so the sensation in the area goes numb.

No wonder researchers are worried about someone being iced up going back into play: they aren't feeling their limbs properly and spatial awareness would go south. The authors only hint at this being their concern:
In addition to the potential risk of injury [?? is it proprioception/senstation being deadened? -mc], the effect of cryotherapy on functional performance is a relevant concern, especially if the athlete plans to return to practice or competition immediately after the treatment.
These authors are not the first to be concerned with the effects of icing prior to athletic endeavor. They site over a dozen studies that have come up with conflicting results about its impact on performance.

But wait. Aren't you hurt if you're icing?
What is interesting to me anyway, here, is that we're dealing with an athlete who has an injury, or they wouldn't be getting iced, and the question is what effect will icing have on their vertical jump? Ok, we're testing with un-injured participants, that's one (ethics and all but who's to say the effects are the same with someone with an injury), but isn't there a sort of fundamental ethical conundrum about asking someone who is so f'd up that they need to be icing in the first place then to go back into the game? The authors write in their Discussion section
Our study provides additional insight regarding the effect of cryotherapy on a major muscle group while performing functional activities. We wanted to provide clinical relevance to practicing certified athletic trainers; hence, we chose ice bag application because it is the most widely available form of cryotherapy. The time of application also coincides with the clinical relevance of the study. Our rationale for this includes circumstances in which the athlete will be returned to play after ice treatment of short durations. In some instances, an athlete will remove the ice bag early (within 10 minutes) and return him- or herself to play without clearance by a certified athletic trainer. We also examined the effect of these ice treatments after 20 minutes of time had elapsed; we found that as little as 10 minutes of ice can still detrimentally affect functional performance, as shown by the shuttle run in our study.
I guess other questions would be, so what? We now know that three minutes has no impact on power, but ten minutes does. But isn't the question about the status of the injury? not about the overall minimal effect on power? What's the likelihood that with that slowed down effect that they'll reinjure themselves or be better protected? That doesn't get discussed.

What the others do note in practical applications is
Certified athletic trainers, athletes, coaches, and practitioners often apply ice to an injured athlete during practice or games. There are often times when athletes feel that they are ready to go back into competition, and they do not complete the total application time for the cryotherapy session. Our findings suggest that a 3-minute application does not affect the functional test measures, but a 10-minute application affects vertical jump and shuttle run times. An athlete may not be able to perform at his or her optimal level after a 10-minute application of cryotherapy even though the cryotherapy was applied to a secondary muscle group; therefore, we should use caution in returning the individual back into competition because there may be other deficits that have not yet been identified. Further research is warranted on primary muscle groups and on the use of short-term cryotherapy applications.

What are the authors saying? 10 mins may impact their performance so ten minutes is too long? But while three mins doesn't that's ok, send them back in? The authors leave the question hanging as to whether three mins. of icing, has that had a good effect, though, at all.

Or *maybe* the whole idea is stupid?

Here's my question: why does the athlete need to be iced? - assuming icing is in any way a good idea.

Here's the follow up questions:
If someone has such a degree of pain or inflammation that they need to be iced, what evidence is there to suggest that a three minute shot of ice has made the tissue situation sufficiently ok to enable a full re-introduction back into play in the first place?

Now maybe there is super evidence to support this: that staying moving is a good idea. There's tons of work in pain that pain does not equal injury, but let's say there is an injury, what are we doing here with the ice bag? Where is the work that shows in cases such as these - the athlete keen to get back in the game - that that's been a Wise Move in and of itself?

As said, there may be, and maybe that literature is so well known the authors haven't felt the need to site it, but that that issue doesn't even get a mention makes me think, maybe not.

Saturday, July 25, 2009

Is what's on the label really in your supplement?

Most of us into health and nutrition dabble in supplements. Some whey protein here; a vitamin D capsule, maybe some fish oil, there. We do this because we believe what we've read about these things being a good idea. But what if what's on the label isn't what's in the tin? How do we really know we're getting what's promised by the label?
At the recent Z-Health 9S:sustenance course, overviewed here, we talked a lot about supplements: about what ones are worth taking, yes, but also about where to source them, once you've made the decision to use them. Based on that discussion, i did some further digging. It's not a story with a happy ending. Sorta more like left who's on stage at the end of Richard III: oh goodie the exciting, poetic, smart villain is dead, while this cheating asshole is left to run the kingdom but at least no one will be fighting anymore. hoo frickin' rah.

So this post presents a brief overview of legislation in the US around dietary supplements, problems with supplement quality and contamination, what good manufacturing practice (aka cGMP is) what third party certification like Consumer Labs or USP does with GMP (overivewed, anyway), a glimpse at the EU situation, and why June2010 is not the end of the War of the Roses.

History and Current Unregulated Practice. In the US, since 1994, there's been no requirement to have the Food and Drug Administration (FDA) assess either what goes into supplements or how they're made. Indeed, the FDA explicitly does NOT certify supplements (the way it does drugs and biologics). As its own web site says:
FDA does not approve dietary supplements.
Unlike new drugs, dietary supplements are not reviewed and approved by FDA based on their safety and effectiveness. Most dietary supplements that contain a new dietary ingredient (a dietary ingredient not marketed in the United States before October 15, 1994) require a notification to FDA 75 days before marketing.

The notification must include the information that was the manufacturer or distributor's basis for concluding that the dietary supplement will reasonably be expected to be safe. After dietary supplements are on the market, FDA evaluates their safety through research and adverse event monitoring.
Why might such oversight at the level of the FDA be important? Well, our fave sup companies might not be delivering the goods. Consider this story from June this year on a consumerlabs.com test of various supplements:
Potency problems
In ConsumerLab.com testing last November, four out of seven supplements contained less ginkgo than claimed on their labels, and one failed to break apart properly to release its ingredients. Seven out of nine failed in tests in 2003, as did six out of 13 in 2005.
"It is now believed that ginkgo is among the most adulterated herbs," the company reports.
Tests by California scientists of two dozen ginseng supplements, reported in a nutrition journal in 2001, found that many differed from their labels. The concentrations of some ginseng compounds varied by up to 200-fold from product to product.
In ConsumerLab.com tests, six out of nine chondroitin supplements failed testing in April 2007. One had only 8 percent of what it claimed to contain, and one "maximum strength" product had none.
Vitamins and minerals had problems, too. A "high potency" iron supplement contained less than half the amount claimed. Of 23 top-selling vitamin C pills, one provided less than half the amount promised; the suggested dosages of some others were beyond recommended safe levels. Of 10 vitamin A supplements, one provided twice its stated amount, raising concern about toxic side effects.
Last year, nearly 200 people were sickened by supplements containing up to 200 times the amount of selenium stated on the label. Symptoms included hair loss, discolored and painful fingernails, muscle cramps, joint pain, diarrhea and fatigue.
Ok they above sounds like a rip off: claiming to have something in it that just isn't there. But the problems don't stop there. What about putting crap into the supplement that isn't on the label and may be a banned substance or just some crap drug? This too has apparently happened:
Spiking Your Shake
"Random batch spiking" has a long history in the supplement business. It works like this: "The manufacturer sprinkles an illegal substance into an over-the-counter dietary supplement," says Feliciano. "The legal ingredients are claimed on the label, but they don't disclose the drug."

Chris Lockwood, formerly the senior category director of diet, energy, food, and beverage at the supplement retailer GNC and now a doctoral candidate in exercise physiology at the University of Oklahoma, recalls taking a popular protein powder in the early 1990s: "When I first took it, I got great gains. I felt great. I got strong. I got lean. But then something happened to it." Years later, he related his experiences to one of the product's formulators who confirmed for him that the powder had been spiked with Clenbuterol, an asthma drug that supercharges your metabolism.
So what is a consumer to do?
There are in the US alone about 4 various standards groups that certify supplements against the Good Manufacturing Process. These are Consumer Labs, mentioned above, the NSF, NPA and USP (we'll come back to these in a second). According to Wikipedia's entry on cGMP, this means,
Since sampling product will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment itself. An extremely important part of GMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered contaminated (adulterated in the US). Additionally, GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s).
Process Check vs Spot Check. In other words how the stuff is made is checked, not just a given batch "randomly" selected to be tested by a lab. On some bulk supplement sites, they will post batch "certificates of purity" as a kind of quality control - and a person then has to take it on faith that that certificate matches up with the batch actually in the holder's control and that is then being parceled out from that batch (in another process, introducing another opportunity for contamination) into smaller tins.

In contrast, with GMP, the process of how a supplement is made is submitted to the certification body, assessed against the certification group's standards, and then audited in practice. The specific details of each group's auditing process are detailed on their sites, but here are the types of things they consider for certification:

USP (US Pharmacopia)
The USP Verified Mark helps assure consumers of a manufacturer's commitment to quality and helps them easily identify and choose a product that
  • contains the ingredients listed on the label, in the declared potency and amount
  • does not contain harmful levels of specified contaminants
  • will break down and release into the body in a specified amount of time
  • and has been made according to the FDA's Good Manufacturing Processes
A list of USP cert'd supplement companies can also be found on their web site.

"Will break down and release into the body" is a pretty important thing, isn't it? Seems obvious, but some supplements in those ConsumerLabs.com random tests have been shown to be inert - they don't break down at all even in acid, never mind water, like ever.

NSF
What does NSF certification of a dietary supplement mean to consumers?
NSF International was one of the first organizations to develop an independent product evaluation program to address the rapidly growing dietary supplements industry.
The purpose of our voluntary program is to test and certify dietary supplements products to
  • verify the identify and quantity of dietary ingredients listed on the product label;
  • ensure the product does not contain undeclared ingredients or unacceptable levels of contaminants; and
  • demonstrate conformance to currently recommended industry Good Manufacturing Practices (GMPs) for dietary supplements.
They seem to be missing that disolvability eh? But you can also check if your brand uses the NSF for their certification. Likewise if you're concerned about banned substances, NSF makes a business of certifying for this compliance, too.

Why so many certification labs? It's a business. NSF also tests tools. ConsumerLabs tests everything. USP and NPA don't. Why might a company choose one cert over another? Good question. Certifications cost money. One might also believe that the auditing practices of one group seem more amenable than another. It's worth digging into each program to see what you would find most comforting.

Natural Products? For instance, some of us like to privilege "natural" products in our supplements over synthetics. Whether there is a clear difference in terms of absorption or not can be debated, and indeed the vitamin D2 vs D3 debate is a great example of such a discussion (though vitamn D2 is from natural products that are vegetarian sourced and then irradiated rather than from squished fish and animal parts, but i digress).

For that preference, there is a GMP certification group focusing on standards for naturals. Called, naturally enough, the Natural Products Association. Their guidelines for GMP spec are quite detailed, too. They have a considerable list of companies on their listings as well, and it's great that these can be checked.

UK/EU
In the EU, the standards seem to be incredibly weak. Ya have to demonstrate that in quantity and quality, they are safe. Placebo is safe: having nothing in the supplement including what's on the label, is safe. Despite this breadth, the UK fought them: why pay money to say what you've been selling for years is safe, went the argument - at least in part. Gosh, sport, i dunno. Maybe it's NOT. That said, some folks think the legislation is protecting law makers rather than conusmers. But then what IS a consumer to do who wants to make sure what's on the label is what's in the tin?

In the UK, some companies do send their products to be tested. But that's product testing, not product process auditing. When they want to prove their goodness in terms of GMP, they can go the ISO (international standards) route and get ISO 9001:2008 accreditation.
ISO 9001:2008 specifies requirements for a quality management system where an organization
  • needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
  • aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
So far, myprotein.co.uk, claims to be the sole UK supplement maker with the 9001:2000 certification, never mind the ultra recent 2008 version (it takes the better part of a year or more to get to that certified process so no wonder myprotein has just been able to announce the slightly earlier standard).

Becuase i say so? Another company that makes natural products in the UK and claims to use Good Manufacturing Practice, for made-in-uk supplements, however, doesn't say how that claim is verified.
Another supplement shop suggests that GMP in the UK is self-regulated: it's GMP compliant if we say it is:

What is GMP?
Good Manufacturing Practice (GMP) offers quality assurance; it is a set of strict pharmaceutical regulations, codes, and guidelines that ensure that food supplements are constantly manufactured and controlled to a high standard which is suitable for use. Within the UK it is only legally applicable to medicines and veterinary medicines, however, GMP is a self-regulatory code within the supplements industry which is used alongside the regulations that are set out within the Food Supplements Directive.

Simply Supplements’ purchasing team ensure that all of our supplements comply with the Food Supplements Directive and that countless products are GMP certified.
I have not been able to find anything to show either that there is anything other than a shop claiming that their supplements follow GMP protocols in order to claim GMP "certified." That said, it seems like the only real EU-wide objective approach is the ISO 9001:2000/2008 certification. As in the states, there are a variety of groups set up to help organizations meet these criteria and get their practices assessed by accredited labs.

June 2010: Law comes back to the Supplement Wild West - sort of. Back in the states, apparently by June 2010, supplement companies will have to be compliant with minimum GMP to sell their wares (pdf of whole rule here). Hoorah. Sounds wonderful, doesn't it. Here's the irony. Remember, this law/ruling is for Dietary Supplement makers. So watch this exception:
The most important and obvious change is that the final rule does not apply to dietary ingredient suppliers and manufacturers. The burden of compliance with cGMPs fully lies with the dietary supplement’s manufacturer and requires dietary supplement manufacturers to test 100% of the incoming dietary ingredients.
Excuse me? So this sort of means that while manufactures have to be able to say what their processes are and list that their processes follow GMP, and that will take some cost and effort, who's to say what's on paper is what they do? Who is going to police this? The FDA itself is woefully understaffed. And while it can carry out random inspections, is the cost of a fine cheaper than the cost of changing manufacturing practice?

GMP - better than a kick in the head. There's something to be said, perhaps, for companies who have taken it upon themselves to pick up the cost of quality assurance third-party certification. There can be corruption everywhere, to be sure. Inspectors paid off, etc etc, but for the most part, why bother with the certification then? There seem to be a thriving fleet of businesses making money on supplements without any breath of certification.

So, take away: the above may help explain why some products cost a *little* more than others. Certification is not the big cost, but production mechanisms, practices and oversight for compliance DO cost more.

If the result of that process is both a safe-from-contaminent and quality product such that what's on the tin is *in* the tin, then that is value for money.

If you're not sure if your favorite supplement shop is GMP certified by a third-party, why not ask them? If enough people do ask, they might up their game. They may say no, they can't afford to raise prices. Likewise, you may decide it's too great a risk of potentially wasting your money *not* to get your sups from a GMP certified source.

ps - supplements that are likely *worth* investing in, based on the best of what we know?

  • fish oil or equivalent broad spec fatty acids
  • vitamin d
  • coq10
for performance ergogenics, additionally
  • protein/bcaa
  • creatine
if not confident of the vitamin quality of one's food:
  • a multi
  • some e
  • some magnesium
If into strength stuff

whey protein, creatine, b complex - the research on these guys is so long standing now and so repeated in terms of results, it's hard to argue. THough i would say pea protein and rice protein are also great alternatives - as algae oil seems to be for fish oil.

So for the few things that have been shown to add real benefit, may be worth chasing down the ones with the highest certified potency/quality/purity?
 

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