Trial Report RESTORE ME: A RCT of Oxaloacetate for Improving Fatigue in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), 2024, Cash et al

RESTORE ME: A RCT of Oxaloacetate for Improving Fatigue in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Alan B. Cash, Suzanne D. Vernon, Candace Rond, Saeed Abbaszadeh, Jen Bell, Brayden Yellman, David Kaufman

*[Provisionally accepted, full text not yet available]*

Abstract
The energy metabolite oxaloacetate is significantly lower in the blood plasma of ME/CFS subjects. A previous open-label trial with oxaloacetate supplementation significantly reduced ME/CFS fatigue.

In a follow-on trial, 82 ME/CFS subjects were enrolled in a 3-month randomized double blinded controlled trial using 2,000 mg oxaloacetate or control/day. The primary endpoints were safety and a reduction in fatigue from baseline. Secondary and exploratory endpoints reviewed functional capacity, and general health status.

Results: Anhydrous enol-oxaloacetate (oxaloacetate) was well tolerated at the doses tested. Oxaloacetate significantly lowered fatigue from baseline by >25%, whereas the control group was not significant at ~10% reduction. Intergroup analysis of oxaloacetate and control measured shifted fatigue to lower levels in the oxaloacetate group (P= 0.0039), but with no significant shift in the control group. The oxaloacetate group had a higher percentage of subjects achieve a > 25% reduction in fatigue compared to the control group (P< 0.05). A subset of subjects that comprised 40.5% of the oxaloacetate group were "Enhanced Responders" with a 63% average fatigue reduction.

Both physical and mental fatigue were improved by oxaloacetate. Oxaloacetate is well-tolerated and helps to reduce fatigue in ME/CFS.

Link (Frontiers in Neurology)

 

The first author (Alan B. Cash) works for a company that produces oxaloacetate.
(just pointing it out)

 

I posted my results on the other thread. My levels were very low. They are referring to the supplement as 'medical food grade'. What does that mean exactly?

Here we have clinical trials using Anhydrous Enol-oxaloacetate for brain function fatigue in cancer patients. I'm pretty sure they're not experiencing delayed PEM.

LINK

 

The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."
https://www.fda.gov/food/guidance-d...ods-guidance-documents-regulatory-information​

 

Ok, so is food grade considered the same as pharmaceutical grade that falls under the same classification as a drug?

 

I think pharma grade means there are stricter standards than medical food grade. (But I am not a specialist in "FDA speak")

 

Looks like a follow-up to this paper? (now with a disclaimer added as of 10/3/2023)
Oxaloacetate Treatment For Mental And Physical Fatigue In Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Long-COVID fatigue patients: a non-randomized controlled clinical trial

Discussed in this thread

 

There area number of unclear aspects to the abstract text that worry me. We should be getting a straight report of a predefined primary endpoint. It is very unclear what the p value of 0.0039 refers to. If the study is robust it is important so why not write a clear abstract?

 

Provisionally accepted usually means subject to some required improvements!!