RESTORE ME -- RCT of Oxaloacetate on Improving Fatigue in ME/CFS
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|ClinicalTrials.gov Identifier: NCT05273372|
Recruitment Status : Enrolling by invitation
First Posted : March 10, 2022
Last Update Posted : March 10, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Myalgic Encephalomyelitis Chronic Fatigue Syndrome Fatigue||Other: Placebo Other: Medical Food - Anhydrous Enol-Oxaloacetate||Not Applicable|
Anhydrous Enol-Oxaloacetate is a patented thermally stabilized oxaloacetate compound with a multiple year stability rating that when ingested forms bioidentical oxaloacetate. Oxaloacetate is a human metabolite involved in many biochemical reactions in the cytosol and mitochondrial, and is key to energy production.
The investigators will conduct a randomized double blind placebo control trial to determine the effects of AEO on improving fatigue in ME/CFS. The primary measurement with be the Chalder Fatigue Score. The trial will be performed at one site, the Bateman Horne Center, which specializes in the treatment of ME/CFS. The trial will also evaluate the effect of AEO on other core ME/CFS symptoms, health related quality of life as assessed by the SF-36, hours of upright activity, functional capacity (upright activity, steps, cognition, and heart rate variability) and general health status (global change, vitals). The trial will also gain preliminary insights on the safety, tolerability, and efficacy of AEO in ME/CFS patients.
Treatment in the trial will be over a 90-day period for each patient. Participants will be primarily recruited from Bateman Horne's current patients and BHCs databases of research participants. Participants will be screened by telephone for potential eligibility, and if eligible, will be invited to an in person visit at Bateman Horne Center to further confirm eligibility and obtain informed consent. Evaluation will include assessment of vital signs, weight, determination of 5-minute a standard 12-lead electrocardiogram to determine heart rate variability (HRV), cognitive testing, and collection of a fasting blood. Women who could potentially be pregnant will undergo pregnancy testing. Participants will complete baseline questionnaires that assess ME/CFS symptoms, and will undergo cognitive testing, along with a blood draw for biobanking for future banking and eventual metabolomic testing that could include assays such as metabolomics, lipidomics and transcriptomics. Subjects will be provided with a device to wear on their ankle that will determine daily steps and upright activity.
On Visit 1 participants will receive two bottles of 90-day supply of the study capsules treatment and will be instructed to take two 500 mg capsule at breakfast and again at lunch. When participants return for Visit 2, they will bring the bottles of study product with them. BHC will take account of the initial 4-week supplies of the product remaining and provide the participant with another bottle of product. When participants return for study dietary supplement will be distributed at Visit 2 and Visit 3, they will bring the bottles of study project with them, BHC will take account of the remaining product and provide the participant with another bottle. For the final Visit 4, participant will bring the bottles of study product with them and BHC will take account of remaining study product.
Participants will be contacted once every two weeks by the study coordinator to assess for any side effects or difficulty taking the study dietary supplement. They will be asked to return for an in person visit every 4 weeks for 90 days at which time any symptoms or toxicities will be formally documented, and they will complete follow-up questionnaires to assess symptoms, cognition, and heart rate variability. After 12 weeks there will be a final in person visit with a final physical examination, 5-minute HRVEKG, cognitive testing, and symptom assessment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Placebo-controlled double blinded 2 arm study. 40 patients in treatment arm, 40 patients in placebo arm.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||2 sets of bottles will be delivered to the Bateman Horne Center-- Group 1 and Group A. One of the groups will contain the active, the other the placebo.|
|Official Title:||A Randomized Double Blind Placebo Controlled Trial to Determine the Effects of Oxaloacetate on Improving Fatigue in ME/CFS|
|Estimated Study Start Date :||March 15, 2022|
|Estimated Primary Completion Date :||November 30, 2022|
|Estimated Study Completion Date :||December 31, 2022|
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.
Other: Medical Food - Anhydrous Enol-Oxaloacetate
Active treatment with oxaloacetate. 1,000 mg BID
Other Name: Oxaloacetate
Placebo Comparator: Placebo
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.
Placebo treatment with the food white rice flour. 1,000 mg BID
Other Name: White Rice Flour
- Reduction of Fatigue [ Time Frame: 90 days ]Reduction in fatigue, Likert Scoring, on the Chalder Fatigue Scale 0-33 Point Scale, with 0 being no fatigue, and 33 being maximum measurable fatigue
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 90 days ]Comparison of adverse events in the treatment group as opposed to the placebo group
- Physical Functioning on the SF-36 [ Time Frame: 90 days ]Evaluation of the SF-36 for physical functioning, role physical, bodily pain, and others
- Patient Global Impression of Change Questionnaire, 7 point scale, -3 to +3, with the higher score indicating more improvement [ Time Frame: 90 days ]Measurement of patlient's rating of overall improvement
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05273372
|United States, Utah|
|Bateman Horne Center|
|Salt Lake City, Utah, United States, 84102|
|Principal Investigator:||Suzanne D Vernon, Ph.D.||Bateman Horne Center|