Closed USA: RESTORE ME: A RandomizEd Double Blind Placebo Control Trial to Determine the EffectS of OxaloaceTate On ImpRoving FatiguE in ME/CFS

The Bateman Horne Center is working with Terra Biological to test oxaloacetate, a nutritional supplement, in ME/CFS. Oxaloacetate is an energy metabolite that holds a key place in the TCA cycle – the cycle that is essential for the generation of energy. Half of the participants will receive capsules containing oxaloacetate and half will receive capsules with rice flour which will serve as the placebo.

The trial will last for 90 days. During this time there will be four (4) in-person visits to the Bateman Horne Center for a physical exam, assessments, blood collection, and fitted with a device to measure daily steps and upright position. Participants will be emailed short surveys to complete on a weekly basis throughout the trial. At the end of the study, participants that received a placebo will be provided with a 90-day trial of oxaloacetate if they are interested. Eligible participants will be compensated $50 for each in-person visit.

If you are interested in learning more about this study, please contact us by:

Emailing: research@batemanhornecenter.org or call (801) 532-8311

https://batemanhornecenter.org/research/#active-recruiting

 

Someone needs their acronym privileges removed!

Oxaloacetate is part of the citric acid cycle, but I am not overly confident this will have much effect.

 

"Citric acid is a so-called tricarboxylic acid, containing three carboxyl groups (COOH). Hence the Krebs cycle is sometimes referred to as the tricarboxylic acid (TCA) cycle."

When I did my degree in Physiology and Biochemistry many years ago it was mainly called the Krebs cycle.[/QUOTE]

I doubt it will have much effect either, especially if the problem is at the level of pyruvate dehydrogenase,as a couple of researchers have thought

 

Possibly the most cringe-inducing study acronym that I've seen in ages

 

Sorry, I meant CRYING: Possibly the most Cringe-inducing study acRonYm that I've seeN in aGes

 

You get to keep your acronym privileges!

 

Some alternatives, generated by https://acronymify.com/

TIRESOME - TrIal deteRmine EffectS Oxaloacetate ME/cfs
MEDDLESOME - randoMizED Double bLind EffectS Oxaloacetate ME/cfs
MEDIOCRE - randoMizEd Double blInd placebO Control tRial mE/cfs
IRRITATE - randomIzed tRial deteRmIne effecTs oxAloacetaTe mE/cfs
DOMINATRICES - ranDOMized blINd plAcebo conTrol tRial determIne effeCts oxaloacEtate me/cfS

 

Reposting @LarsSG’s post on the thread on Dr Kaufman’s oxaloacetate trial:

This sounds very unpromising.

 

Brilliant Andy.

 

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

 

CLINICAL TRIAL article

Front. Neurol.

Sec. Experimental Therapeutics

Volume 15 - 2024 | doi: 10.3389/fneur.2024.1483876

This article is part of the Research TopicFatigue: Physiology and Pathology, Volume IIView all articles

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

Alan B. Cash 1* Suzanne D. Vernon 2 Candace Rond 2 Saeed Abbaszadeh 2 Jen Bell 2 Brayden Yellman 2 David Kaufman 3

1 Terra Biological LLC, San Diego, United States2 Bateman Horne Center, Salt Lake City, Utah, United States3 Center for Complex Disease, Mountain View, CA, United States

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.

 

Why would oxaloacetate be lower to start off with?

What could drive that process?

Could lower oxaloacetate have a protective effect?

 

The evidence of low oxaloacetate in ME/CFS seems to come from a cohort of 17 patients studied by Maureen Hanson's group. I have not heard of it being found by others. I wonder if it might simply reflect dietary patterns of people with ME/CFS. It might also be a chance finding in an initial metabolic trawl.

https://pubs.rsc.org/en/content/articlelanding/2017/mb/c6mb00600k