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Medical Food - Anhydrous Enol-Oxaloacetate for Chronic Fatigue Syndrome

N/A
Waitlist Available
Led By Suzanne D Vernon, Ph.D.
Research Sponsored by Terra Biological LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study Summary

This trial will test if a potential new treatment, anhydrous enol-oxaloacetate (AEO), can help improve fatigue in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

Eligible Conditions
  • Chronic Fatigue Syndrome
  • Fatigue

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction of Fatigue
Secondary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Patient Global Impression of Change Questionnaire, 7 point scale, -3 to +3, with the higher score indicating more improvement
Physical Functioning on the SF-36

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OxaloacetateExperimental Treatment1 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: PlaceboPlacebo Group1 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.

Find a Location

Who is running the clinical trial?

Terra Biological LLCLead Sponsor
6 Previous Clinical Trials
227 Total Patients Enrolled
Bateman Horne CenterOTHER
2 Previous Clinical Trials
130 Total Patients Enrolled
Suzanne D Vernon, Ph.D.Principal InvestigatorBateman Horne Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals eligible to participate in this experiment presently?

"Per the documentation on clinicaltrials.gov, recruitment for this study has concluded as of February 28th 2022. This research was first listed on March 15th 2022 and is one out of 225 other trials currently looking to enrol participants."

Answered by AI

Can geriatric individuals volunteer for this research investigation?

"This clinical trial seeks participants between the ages of 18-70. There are 13 distinct trials for minors, and another 179 available to those over 65 years old who meet other criteria."

Answered by AI

What qualifications must a patient possess to partake in this trial?

"This clinical trial is recruiting 80 fatigued individuals aged 18-65. Participants must meet the following conditions to be eligible: provide written consent, have a basic command of English, satisfy IOM Diagnostic Criteria for ME/CFS (2015), report 2-6 hours daily upright activity in preceding 3 months, male or female gender, no active SARS-CoV-2 infection at enrollment visit 1 and adequate contraception such as oral contraceptives with one full cycle prior to administration of study drug; intrauterine devices (IUDs); vasectomized partner; double barrier method with spermicidal jelly or cream use simultaneously"

Answered by AI

Who else is applying?

What state do they live in?
Quebec
Hawaii
Colorado
Other
How old are they?
65+
18 - 65
What site did they apply to?
Bateman Horne Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I want to be able to do sports and walk longer. I have tried everything else for years just hoping to find something to help.
PatientReceived no prior treatments
I'm severe and bedbound 95% of the time. I tried differents supplements and technic. I'm not getting better, but getting worse. I want to make myself better and maybe help others in the ways.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

When is it starting? How soon will the trial begin and how long?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Bateman Horne Center: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
~26 spots leftby Apr 2025