Biometrics

March 15, 2011

" Clinical Trials " of Nutraceuticals: Science or Scam?

linda von Wartburg

Mar 14, 2011

In the pharmaceutical industry, a double-blind, placebo-controlled clinical

trial is a tightly regulated process that tests the safety and efficacy of

drugs. Every safeguard is in place to prevent the results from being tainted

by the interests of the investigators or sponsors, so a successful clinical

trial is the best guarantee we have that the drug is safe and effective.

But what about in the nutraceutical business, which is not regulated by the

FDA and is not required to support their claims with clinical trials? The

words " clinical trial, " and the guarantee they imply, still have power to

instill trust, a power that some nutraceuticals are trying to harness in the

interest of marketing.

One example of a product whose manufacturers are very enthused about

clinical trials is DiaMetrix. DiaMetrix is a nutraceutical composed of 20 mg

of vitamin <http://www.diabeteshealth.com/browse/food/vitamins/> C, 200 mcg

of biotin, 200 mcg of chromium, and 3200 mg of various herbs, that is

marketed to people with type 2

<http://www.diabeteshealth.com/browse/community/type-2-issues/> diabetes

<http://www.diabeteshealth.com/> , ostensibly to lower blood sugar

<http://www.diabeteshealth.com/browse/monitoring/blood-sugar/> .

On its website, you find the following: " Ask yourself this question: Is the

product I'm about to put into my body supported by a double-blind clinical

trial? Most believe that it's possible to know if a natural approach works

by simply trying it....What you should be asking is 'Show me the

double-blind study and I'll pay attention.' Otherwise, it's little more than

hot air. "

Nothing to argue with there. But how does a nutraceutical go about getting a

clinical trial? And does getting one prove that their claims are more than

hot air?

It all depends on how the clinical trial is performed.

When Ken Hampshire and his colleagues decided to get themselves a clinical

trial of DiaMetrix in 2007, they contacted Montgomery of Fenestra

Research in Las Vegas, Nevada, perhaps enticed by this information on the

Fenestra website:

" It is important to understand that while the research is double blind and

un-biased, Melonie and Fenestra Research are 100% on your team. Reports are

written to highlight product benefits. Take your nutritional product sales

to new heights by partnering with Fenestra Research. Make us your

ally...Before Your Competition Does...Contact Fenestra Research today for

Special Promotional Pricing. "

Apparently Fenestra is quite a bargain as clinical trials go. As their press

release notes:

" While comparable human clinical studies can often run into the $200,000 to

$400,000 range,...the Fenestra Research Labs marketing advantage is that

their studies can cost as little as $30,000 and are by far the most

cost-effective and conclusive clinical trials available in the marketplace

today. "

Fenestra's previous " clinical trials " have supported the claims of a diverse

group of concoctions and devices, including the Stirwand, a pen-sized

plastic container filled with " granulated mineral " whose " primary function

is to increase the hydration potential of water....The minerals do NOT leave

the container - it's the energy of the minerals that does the magic. "

According to the manufacturer, stirring a glass, or even 500 gallons, of

water with one of these 90-dollar plastic sticks will change the properties

of the water, such that you will be more hydrated by drinking it than by

drinking the original, unstirred water. They go on to say, with reason, if

not clarity: " Convention will debate this, as inert objects traditionally do

not produce substantial results in water. In this case however, a quantum

phenomenon trumps a Newtonian fundamental. "

According to Fenestra's " clinical trial " of the Stirwand, it indeed does.

Fenestra Research conducted " a 90 day controlled study " that purportedly

" showed an average increase in hydration of the participants that used the

Stirwand of nearly 30%. It also showed increased blood oxygen levels of over

10% and decreased cellular toxins by over 18%. "

If you'd rather not use a Stirwand, you can get another brand of plain water

that was tested by Fenestra. According to Montgomery, " GlaciaNova's Glacial

Water product is the most hydrating water product we have ever tested....It

has shown an average 38.2% intracellular hydration improvement whereas all

other commercially available water products we have tested so far have shown

less than 5% hydration increase on average with only few exceptions. "

In her report on LifeWave patches, which are regarded as a hoax by the

Worldwide Scam Network, Montgomery wrote: " We find that the daily use of the

Energy Patches by LifeWave Products did improve the energy levels in 100% of

our test subjects. This was proven using the Fenestra Research Labs Optimal

Wellness Test. " The Optimum Wellness Test is a urine and saliva test

invented by Ms. Montgomery that is purported to " identify and measure 34

clinical markers in human physiology to a very high degree of accuracy and

conclude the level of 'wellness' exhibited by individual clients. "

" Dr. " Melonie Montgomery, the owner of Fesestra Research, is described on

her website as " scheduled to complete her PhD In Holistic Nutrition in early

2006. " Her masters degree is from Clayton College of Natural Health, an

unaccredited online company that recently closed. Montgomery's LinkedIn

profile states that " We do Clinical Studies on mostlynatural [sic] products

for human and equine product [sic]. We can help you prove your products are

safe and effecitve [sic] as well as support marketing claims. "

So what happened when DiaMetrix was tested by Melonie Montgomery of Fenestra

Research? As Mr. Hampshire, the product formulator, said, " The results were

pretty impressive! We saw all of the participants get tremendous improvement

on the A1C <http://www.diabeteshealth.com/browse/monitoring/a1c-test/>

side " and other remarkable improvements which were " ...unheard of with any

product in a clinical study, be it natural or pharmaceutical. "

Clearly, Fenestra Research came though on its promise.

That wasn't the end of the testing story for DiaMetrix, however. Mr.

Hampshire said,

" We were very excited about these results, of course, and we were then

challenged to try to understand a little bit more about the mechanisms of

action. " So they arranged with Dr. Rob Streeper to do a head-to-head

comparison of DiaMetrix against metformin

<http://www.diabeteshealth.com/browse/medications/metformin/> , Actos, and

Byetta <http://www.diabeteshealth.com/browse/medications/byetta/> in mice.

Because the study was, oddly enough, not designed to compare the effects of

DiaMetrix on blood glucose, Dr. Streeper emphasized the effect on markers of

inflammation. Said Dr. Streeper, ' " We don't look at high blood glucose as a

kind of lever that can be grasped to control the disease. It's probably more

important to look at the systemic inflammatory markers, because they are the

true mediators of the tissue damage. "

According to Dr. Streeper, DiaMetrix bested the other medications with

regard to " down-regulation on a broad range of inflammatory markers. " His

focus on anti-inflammatory markers as opposed to blood glucose lowering may

be tied to the discussion section of the mouse study, which states that type

2 <http://www.diabeteshealth.com/browse/community/type-2-issues/> diabetes

is an autoimmune disease. That opinion was also voiced very firmly by Mr.

Hampshire, who noted that " it's well supported by a number of studies

showing that obese people have higher circulating inflammatory mediator

levels, and this tends to predispose to the development of diabetes. "

So, what is DiaMetrix actually supposed to do? According to its website,

" Diametrix is designed for a single purpose: to increase the body's

sensitivity to insulin

<http://www.diabeteshealth.com/browse/medications/insulin/> ...It's been

scientifically shown to increase the body's sensitivity to insulin...If

you're looking to lower your blood sugar levels, DiaMetrix is the only

diabetes product specifically formulated to increase your body's sensitivity

to insulin. "

Asked how it does that, Mr. Hampshire responded, " We're not exactly sure how

that occurs. That statement that you found on the DiaMetrix website, I wrote

some years ago, in fact, based largely on the observations that we've had

based on the human clinical and anecdotal stories, thousands of which we've

had over the years. " His own website's cautionsary advice about the

invalidity of anecdotal evidence does not, apparently, weigh heavily with

Mr. Hampshire.

Mr. Hampshire noted that based upon the mouse study, " We know that DiaMetrix

works in much the same manner that Byetta does to get the results that it

does. It's just that it's more effective in some of those mechanisms. " Given

that Byetta is a GLP-1 mimetic with a very complex mechanism of action, that

is quite a leap from a mouse study of inflammatory markers. Dr. Streeper,

who was apparently not ready to make that leap, went on to explain that how

DiaMetrix works to reduce insulin

<http://www.diabeteshealth.com/browse/complications-and-care/insulin-resista

nce/> resistance " is probably best understood by reference to the

literature, especially more recent literature looking at sepsis in intensive

care patients. "

Asked about his other research, Dr. Streeper said, " I've done internal

things, and we've also done contract work for a variety of pharmaceutical

companies in various roles that we've played throughout our careers. I don't

think we can name our customers....We're bound by confidentiality rules, for

other employments we've had. "

Although the people at DiaMetrix appear to be of mixed minds regarding how

their product is supposed to work, they are not reticent about advising

people to take DiaMetrix instead of their prescribed medications. According

to the website, " It would be one thing if pharmaceutical drugs actually

worked and kept blood glucose from rising too high, but for most people,

they don't. Most of our customers add DiaMetrix to their current

regime...The DiaMetrix dosage is gradually increased, while the

pharmaceutical drug dosage is slowly decreased. Ultimately, one can be

substituted for the other. "

Mr. Hampshire added, " This is a decision only they and their doctors can

arrive at, but in our experience, this is exactly what we've found....from

the words of our customers, that's exactly what they have found. "

Apparently, this is one of those times when he does not consider anecdotal

evidence " hot air. "

Whether Mr. Hampshire and the others at DiaMetrix are intentionally using

pseudo-science to manipulate potential customers is a matter for

speculation. There's a lot of money to be made with a successful product,

but perhaps they are just very convinced of their product's efficacy. Still,

the advice on their website is very much to the point: " Medical conditions

are an area of life in which direct, common sense observations aren't

reliable at all. The insights brought to us by double-blind studies has

[sic] been invaluable. It's the only form of unbiased valuation we have. "

Their attempts to scientifically prove their product's efficacy are not

credible, in part because they were carried out by people with an investment

in the results. According to Marcia Angell, an editor of the New England

Journal of Medicine, " It is often possible to make clinical trials come out

pretty much any way you want, which is why it's so important that

investigators be truly disinterested in the outcome of their work.... " Maybe

one of these days, more nutraceuticals will carry out legitimate clinical

trials to test their efficacy. Meanwhile, Fenestra Research is not the

answer.

_____

Categories: Health <http://www.diabeteshealth.com/browse/community/health/>

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<http://www.diabeteshealth.com/browse/community/type-1-issues/> Issues,

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