Creatine Ethyl Ester is a fraud
Source: Elissalowe; moderator of MuscleBuildingNutrition Forums
This document:
http://www.fda.gov/ohrms/dockets/do...rpt0264-toc.htm is an outline of the data submitted to the FDA in support of CEE's status as a "dietary supplement." A couple of factual inaccuracies w/regard to claims made about creatine monohydrate were noted in my previous post.
I had originally assumed that the FDA data represented the entire class of products marketed as "Creatine Ethyl Ether." I was wrong. What I didn't realize at the time (I hadn't read all the dockets there), is that the "evidence" submitted to the FDA was in support of a single, branded supplement: CreEster, which is currently being marketed by MRI under the brand name of CE2 - and being sold primarily through GNC.
w/regard to CE2: data described in the FDA dockets, along with several other sources provide circmstantial evidence that - not only does the stuff not work - it may in fact be mildly toxic. For example, the owners of CreEster (their trademarked name for CEE) conducted two studies on CEE pharmacokinetics in rats, using carbon-14 labelled CEE. The details of both studies are redacted, but the second is described in some detail (
http://www.fda.gov/ohrms/dockets/do...-Six-vol193.pdf):
"
...this second study involved the pharmacokinetics of creatine in the plasma of rats following oral administration of [14C]Creatine associated with ethanol (i.e., the ester vehicle of administration)...this study...was conducted to definitively establish the identity and time course of the products of dissociation and metabolism.
Results from this study...establish that, following oral administration the [14C]Creatine Ethyl Ester is rapidly absorbed from the gastrointestinal tract, with radioactivity being detected in plasma within three minutes following administration. The peak concentration of the associated form (ester) occurred at five minutes following adminstration, and accounted for less than 15% of the total radioactivity present in the plasma. This indicates that its dissociation into creatine and ethanol is rapid and nearly complete within this initial five-minute period. At ten minutes following administration, approximately 2% of the total radioactivity present in the plasma was in the associated ester form, with none detected after the ten-minute time point. The rapid dissociation of the ethy ester in the plasma was accompanied by a concurrent rapid increase in creatine and creatinine levels as suggested in the earlier study...The peak level of creatine in plasma was equivalent to about 12% of the total radiocarbon present and occurred at approximately thirty minutes following administration. The concentration gradually declined, and gave rise to creatinine levels that increased to approximately 80 - 90%, where they remained throughout the duration of this study period.. This pharmacokinetic profile is expected, since creatinine is the known major metabolite of creatine."
(emphasis mine)
The last sentence made my jaw drop, as the kinetics of creatine monohydrate in humans do not show any major increases in serum creatinine after a single, acute dose. In humans, excess creatine is largely excreted as creatine (
http://www.ncbi.nlm.nih.gov/entrez/...870&query_hl=10). This very rapid conversion to creatinine in-vivo is definitely something to be concerned about.
The toxicology data (
http://www.fda.gov/ohrms/dockets/do...port-vol140.pdf) does little to allay suspicion. Rats were gavaged with the equivalent of a 30g/70kg of CEE (430 mg/kg) for seven days. Serum creatinine levels were checked and found to be within normal limits -
but only after the conclusion of the study. Could prior knowledge of the clearance rate determined from the carbon-14 studies have had anything to do with the decision to not perform any analyses on the rats' blood chemistry until after the study was concluded? One wonders. In addition - one of the other measures taken was body weight: and there were "
no significant changes in weight gain between the control and treatment groups over the seven day course of the study." Even acute, short-term studies on CM in humans show weight gain!
Ok - these are rats, not people. But you will search high and low for any legit studies on people. There's one toxicology test described using "five adult males ranging in age from 39 - 64 years. The daily dosage and length of exposure to the supplement ranged from 1.0 to 3.0 grams and 238 to 414 days respectively." Now there's a controlled study for you! (j/k). And even at this low dose, one of the five had a "slightly elevated measurement for serum creatinine of 1.7 mg/dL..." No weight gain or increases in strength were reported for this group, although it certainly would have been easy to obtain this data - assuming there were any changes that were worth reporting on.
The "data" on the owner's web site is a joke. The only positive data reported from their (hinted at) human studies are anecdotal reports of less muscle soreness following exercise!(
http://www.gopnt.com/cgi-bin/bio_view.cgi?p=275). Oh - I forgot...on the FAQ page they also make a (completely unsupported) claim of "more defined muscle."
And, as "Porky Pig" used to say: "Th-th-th-thaaaat's all, folks!"
And all of this dreck pertains to a single brand. What about all the other CEE's on the market?
This is where the going gets wierd. Over at bb.com, for example, there's an info page on CEE (h t t p://www.bodybuilding.com/store/cee.html)...one section is titled "Is Creatine Ethyl Ester Real?" and of course it is! Really! Why they've even got links to certificates of analysis to prove it. And they dare you to click on those links! Cause CEE is too really real! And if you click on those links, then you're gonna see! Really!
So of course, I clicked on the links. And what's there is un-f**king-believable, because the tatty bits of "paper" there offer exactly zero support for the reality of CEE! There are six documents linked there:
#1: From a completely unknown lab: there is no header, no watermark, no indication of who did the test, or what tests were done to confirm the stated 98% purity. Verdict: worthless - test can't be verified.
#2: From "Shanghai Waseta Int'l Trading Co., LTD" (so this stuff's imported from Asia). The tests indicate "99.8%" purity. And what was the test performed? "Determination of Total Nitrogen." Huh? Excuse Me? Verdict: worthless - the test is irrelevant for confirming the presence/absence of CEE
#3: subdivided into 4 parts:
a) An identifiable lab, and an identifiable assay - testing for Creatine ethyl
ether. Creatine ethyl ether? There's a difference between an ester and an ether linkage. But in any event, the test shows no CEE - just creatine, and a small amount of creatinine.
b) A graph of a Near Infrared spectrographic analysis. Again no CEE, just creatine, creatinine and "acids". In fact, at the bottom of the graph it clearly states: "
After carefully reviewing every creatine ester available on the market place, the following results were found: All are regular creatine monohydrate mixed with an acid or without."
c) An analysis of "ThermoLife CrE2" by the same lab as in 3a) - no CEE, just creatine and creatinine
d) Another analysis of ThermoLife CrE2 by an unknown lab and method. The result? "
This product contains NO Creatine ethyl ester hcl."
I've looked at a couple of other COAs as well - there's something wrong with all of them. More often than not, the test used to ID the CEE is not given, so there's no way to verify whether an appropriate method is used or not. And - you know the story...when relevant info's not given, it's almost always because there's something to hide.
How many ways can you spell F - R - A - U - D?
Sorry to go into such detail, but some of this crap is going for big bucks (the CE2 retails for nearly $80.00 for a 1 month supply). Hold onto your $$$.
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