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RESTORE ME -- RCT of Oxaloacetate on Improving Fatigue in ME/CFS

NCT05273372 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-02-04

No results posted yet for this study

Summary

There is no approved treatment for fatigue in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), a condition with as many as 2.5 million people in the US. Initial case studies have shown an improvement in fatigue in ME/CFS with anhydrous enol-oxaloacetate (AEO).

This randomized, double blinded, placebo controlled trial will seek to further evaluate the efficacy of AEO to reduce fatigue in ME/CFS, based on change in the Chalder Fatigue Score (Likert Scoring) of the AEO group against the placebo group at 90 days.

As secondary evaluations on other core ME/CFS symptoms, the investigators are measuring the health related quality of life as assessed by the SF-36, hours of upright activity, functional capacity (activity, steps, cognition, and heart rate variability), and general health status (global change, vitals)

Finally, this test will gain preliminary insights on the safety, tolerability, and efficacy of AEO in ME/CFS patients.

Conditions

  • Myalgic Encephalomyelitis
  • Chronic Fatigue Syndrome
  • Fatigue

Interventions

OTHER

Placebo

Placebo treatment with the food white rice flour. 1,000 mg BID

OTHER

Medical Food - Anhydrous Enol-Oxaloacetate

Active treatment with oxaloacetate. 1,000 mg BID

Sponsors & Collaborators

  • Bateman Horne Center

    collaborator OTHER

  • Terra Biological LLC

    lead INDUSTRY

Principal Investigators

  • Suzanne D Vernon, Ph.D. · Bateman Horne Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-15
Primary Completion
2024-06-15
Completion
2024-11-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05273372 on ClinicalTrials.gov