Oxaloacetate for Chronic Fatigue Syndrome

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Terra Biological LLC

Must not be taking: Stimulants, Immunosuppressants

Disqualifiers: Diabetes, Severe ME/CFS, others

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

82 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a supplement called AEO to help people with ME/CFS who suffer from severe fatigue. AEO supports the body's energy production, which may reduce fatigue. The study will observe the effects of AEO over a period.

Will I have to stop taking my current medications?

The trial requires participants to refrain from taking medications that could affect the study's assessment of the dietary supplement's effectiveness. If you're on medications, you may need to stop them, but it's best to discuss this with the trial team.

Is oxaloacetate safe for humans?

The research mentions oxaloacetate as a nutritional supplement used for fatigue in chronic fatigue syndrome and long COVID, but it does not provide specific safety data. It is important to consult with a healthcare provider for personalized advice. ^{1 2 3 4 5}

How does the drug oxaloacetate work for chronic fatigue syndrome?

Oxaloacetate is unique because it may help with chronic fatigue syndrome by promoting energy production in cells and reducing inflammation, as it has been shown to activate brain mitochondrial biogenesis and enhance insulin pathways in other conditions. ^{6 7 8 9 10}

Research Team

Suzanne D Vernon, Ph.D.

Principal Investigator

Bateman Horne Center

Eligibility Criteria

This trial is for adults aged 18-65 with ME/CFS who've been stable for the past 3 months, can do daily activities for more than 2 but less than 6 hours, and are not pregnant or at risk of becoming pregnant. Participants must meet specific diagnostic criteria for ME/CFS and agree to avoid certain medications during the study.

Inclusion Criteria

I often feel extremely tired and worse after physical activity.

I have been diagnosed with ME/CFS according to the 2015 IOM criteria.

My illness allows me to be active for 2 to 6 hours daily.

Exclusion Criteria

My symptoms are not caused by another mental or physical health issue.

Active or uncontrolled co-morbidities which may interfere with study participation

Pregnancy, or while breast feeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person), telephone screening

Treatment

Participants receive either oxaloacetate or placebo capsules for 90 days

12 weeks

4 visits (in-person), bi-weekly phone check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Anhydrous Enol-Oxaloacetate
• Placebo

Trial Overview The RESTORE ME trial is testing whether a medical food called Anhydrous Enol-Oxaloacetate (AEO) can reduce fatigue in people with Chronic Fatigue Syndrome compared to a placebo. It's a randomized, double-blind study measuring effects on fatigue after 90 days using the Chalder Fatigue Score.

Participant Groups

Group I: Oxaloacetate Experimental Treatment 1 Intervention

500 mg anhydrous enol-oxaloacetate in hypromellose capsules (veggie caps). 2 capsules with breakfast and 2 capsules with lunch (1,000 mg BID) for 90 days.

Group II: Placebo Placebo Group 1 Intervention

500 mg white rice flour in hypromellose capsules (veggie caps). 2 capsules with breakfast and 2 capsules with lunch (1,000 mg BID) for 90 days.

Who Is Running the Clinical Trial?

Terra Biological LLC

Lead Sponsor

Trials

7

Recruited

320+

Bateman Horne Center

Collaborator

Trials

3

Recruited

210+

Findings from Research

In the PACE trial involving 641 participants with chronic fatigue syndrome, serious adverse events were rare, while non-serious adverse events were common, with no significant differences in their occurrence across different treatment groups.

Physical deterioration was most frequently reported after adaptive pacing therapy (APT), affecting 25% of participants, indicating that while treatments did not significantly differ in adverse events, APT may be associated with a higher risk of worsening physical function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome. Dougall, D., Johnson, A., Goldsmith, K., et al.[2022]

Low-dose naltrexone (LDN) has shown potential efficacy in treating chronic immune-modulated disorders, with case reports indicating varied responses in patients with chronic fatigue syndrome, ranging from significant improvement to partial symptom relief.

Despite promising anecdotal evidence and small-scale trials for other conditions, there is a lack of clinical trials specifically investigating LDN for chronic fatigue syndrome, suggesting a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose naltrexone as a treatment for chronic fatigue syndrome. Bolton, MJ., Chapman, BP., Van Marwijk, H.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A preliminary placebo-controlled crossover trial of fludrocortisone for chronic fatigue syndrome. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Treating patients suffering from myalgic encephalopathy/chronic fatigue syndrome (ME/CFS) with sodium dichloroacetate: An open-label, proof-of-principle pilot trial. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Low-dose naltrexone as a treatment for chronic fatigue syndrome. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Stereochemistry and function of oxaloacetate keto-enol tautomerase. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Blood glutamate scavengers prolong the survival of rats and mice with brain-implanted gliomas. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Direct demonstration of enol-oxaloacetate as an immediate product of malate oxidation by the mammalian succinate dehydrogenase. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The neuroprotective effects of oxaloacetate in closed head injury in rats is mediated by its blood glutamate scavenging activity: evidence from the use of maleate. [2013]

10. England pubmed.ncbi.nlm.nih.gov

Oxaloacetate activates brain mitochondrial biogenesis, enhances the insulin pathway, reduces inflammation and stimulates neurogenesis. [2021]