An interventional study of Placebo and Medical Food - Anhydrous Enol-Oxaloacetate in Myalgic Encephalomyelitis, Chronic Fatigue Syndrome and Fatigue, sponsored by Terra Biological LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Terra Biological LLC · Not applicable, Interventional, and Treatment
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Among 86 studies in Fatigue Syndrome, Chronic with a site in United States — 21 open to participants now, 24 under way, none of them phase 3. Fatigue Syndrome, Chronic · United States.
Among the 86 studies in Fatigue Syndrome, Chronic with a site in United States, this one is the 18th largest by enrollment of the 58 interventional ones that give a count, is one of 5 that started in 2022, is one of 30 with no phase, and was the 63rd registered.
264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.
Browse Fatigue Syndrome, Chronic studies →21 of the 86 studies in Fatigue Syndrome, Chronic with a site in United States are open now. Recruiting first, the newest first:
Fred Friedberg · Sites in United States
Ages 18–65
University of Alabama at Birmingham · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
University of California, San Francisco · Sites in United States
Ages 18+ · Healthy volunteers
IMMUNOe Research Centers · Sites in United States
Ages 18–90
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 44 Fatigue Syndrome, Chronic studies recruiting now, 18 (41%) set no upper age limit and 20 (45%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
86 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 17 · Phase 3 1 · Phase 4 5
First in 1994; this study’s year is marked. 5 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 82 is above the median of 60 across 178 interventional studies indexed under Fatigue Syndrome, Chronic.
Median enrollment 50 across the 58 interventional studies, 152 across the 26 observational. Of the 47 that completed or were terminated, 15 (32%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 86 have an industry lead sponsor. The 10 most frequent:
Terra Biological LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.
Terra Biological LLC has 2 studies filed under Fatigue Syndrome, Chronic — fewer than ten, so there is no comparison to draw.
10 of the studies in Fatigue Syndrome, Chronic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06511050Icahn School of Medicine at Mount SinaiLumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome | 2026-12 |
| NCT06585254Icahn School of Medicine at Mount SinaitVNS in Long COVID-19 | 2026-12-31 |
| NCT04049331Seattle Institute for Biomedical and Clinical ResearchTestosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone | 2027-01-30 |
| NCT04542161Weill Medical College of Cornell UniversityAssessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome | 2027-04-30 |
| NCT07600320Icahn School of Medicine at Mount SinaiFareon Open Label Device Clinical Trial | 2027-04-30 |
Add all 10 to your calendar (.ics) → With an account.
Among the 86 studies in Fatigue Syndrome, Chronic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who meet all of the following criteria are eligible to participate in the study:
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Other: Placebo
Placebo treatment with the food white rice flour. 1,000 mg BID
Also known as: White Rice Flour
Active treatment with oxaloacetate. 1,000 mg BID
Also known as: Oxaloacetate
Reduction of Fatigue
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
Time frame: 90 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Comparison of adverse events in the treatment group as opposed to the placebo group
Time frame: 90 days
Physical Functioning on the SF-36
Evaluation of the SF-36 for physical functioning, role physical, bodily pain, and others
Time frame: 90 days
Patient Global Impression of Change Questionnaire, 7 point scale, -3 to +3, with the higher score indicating more improvement
Measurement of patlient's rating of overall improvement
Time frame: 90 days
Plan to share: Undecided — At this time the IPD is not available to other researchers.
Ran from Mar 2022 to primary completion in Jun 2024, 27 months.
Of 78 interventional studies with no phase under Fatigue Syndrome, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 27 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Terra Biological LLC