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Medical Food

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

Diagnosed with ME/CFS and meet the IOM Diagnostic Criteria for ME/CFS (2015)

Relatively stable state of illness for the past 3 months characterized by >2 and <6 hours of daily upright activity

Must not have

Severe ME/CFS with less than 2 hours of upright activity a day

Body Mass Index > 35

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial aims to assess safety and tolerability of AEO, potential side effects aren't specified here. Typically, medical foods may cause digestive discomfort or allergic reactions in some individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can be upright for less than 2 hours a day due to severe ME/CFS.

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My BMI is over 35.

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I am currently taking stimulant medications.

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I have a history of rapid heartbeat.

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I often feel dizzy or faint.

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I have not been treated for conditions like thyroid issues, adrenal problems, or diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction of Fatigue

Secondary study objectives

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.

0 / 9Eligibility criteria met