What side effects are associated with this type of intervention?

Common treatments for Chronic Fatigue Syndrome (CFS) include metabolic support supplements like ubiquinol-10 and oxaloacetate. Ubiquinol-10 has been shown to improve autonomic and cognitive functions in CFS patients, with no serious adverse effects reported in studies. Oxaloacetate, studied for its potential to reduce fatigue in Long COVID patients, has not been associated with significant side effects in the context provided. Broadly, treatments for CFS may include medications for symptom management, such as pain relievers and sleep aids, which can have side effects like gastrointestinal issues, dizziness, and dependency.

What prior FDA approvals exist?

There are no FDA-approved drugs specifically for the treatment of Chronic Fatigue Syndrome (CFS). However, various supplements and medications have been studied for their potential benefits. For instance, ubiquinol-10 has shown promise in improving symptoms of CFS by enhancing autonomic nervous function and cognitive function. The ongoing trial of oxaloacetate aims to explore its efficacy in reducing fatigue and improving symptoms in Long COVID patients, which shares similarities with CFS. This approach focuses on metabolic support and energy production, a novel area of investigation for these conditions.

What other types of research exist?

Promising alternatives to oxaloacetate for Chronic Fatigue Syndrome patients include L-carnitine, which has shown benefits in improving metabolic response and reducing neuromuscular fatigue, and eicosapentaenoic acid (EPA), which has been noted for its role in improving clinical outcomes and lean body mass in cachexia, potentially benefiting energy metabolism in CFS patients.

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Medical Food

Oxaloacetate for Post-COVID Syndrome

N/A

Recruiting

Led By Suzanne Vernon, PhD

Research Sponsored by Terra Biological LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients have experienced moderate to severe fatigue at least 50% of the time over the past 6 months that is not relieved by rest and post-exertional malaise (PEM)

Male or female, 18 to 65 years of age

Must not have

In the last 3 years have they experienced a concussion with loss of consciousness, brain surgery, an automobile accident with head/neck injury, and/or other traumatic brain injury

Symptomatic hypotension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 days

Summary

This trial is testing whether oxaloacetate, a natural energy-producing substance in the body, can help reduce fatigue and other symptoms in people with Long COVID who also have chronic fatigue syndrome. These patients often suffer from severe, long-lasting symptoms that are hard to treat with usual methods.

Who is the study for?

This trial is for adults aged 18-65 with Long COVID and symptoms like severe fatigue, brain fog, muscle pains, and sleep issues. Participants must have had these symptoms for at least six months after a confirmed or suspected SARS-CoV-2 infection. They should not be on medications that could affect the study's results and must agree to use contraception if applicable.

What is being tested?

The REGAIN trial is testing whether Oxaloacetate can reduce fatigue in Long COVID patients who also meet criteria for Chronic Fatigue Syndrome (ME/CFS). It's a randomized study where participants will either receive Oxaloacetate or a placebo made of white rice flour to compare effects.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include allergic reactions to ingredients such as rice flour. As with any medical intervention, there might be unforeseen side effects once the trial begins.

Eligibility Criteria

Inclusion Criteria

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

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I often feel very tired and resting doesn't help, especially after physical activity.

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I am between 18 and 65 years old.

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I often feel very tired and resting doesn't help, especially after small tasks.

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I have been diagnosed with Long COVID following a COVID-19 infection.

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I can attend all 3 in-person visits required by the study.

Exclusion Criteria

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

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I have not had a concussion, brain surgery, or a serious head injury in the last 3 years.

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I experience symptoms of low blood pressure.

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I have used oxaloacetate before.

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I have a fast heartbeat originating from the upper or lower chambers of my heart.

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I have not taken stimulants in the last 14 days.

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I have untreated or uncontrolled depression or hormone-related conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 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

Chalder Fatigue Score

Secondary study objectives

Global Impression of Change

Up-Time

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Oxaloacetate ArmExperimental Treatment1 Intervention

1,000 mg of Anhydrous Enol-Oxaloacetate taken BID with Breakfast and Lunch

Group II: Placebo ArmPlacebo Group1 Intervention

1,000 mg of white Rice Flour taken BID with Breakfast and Lunch

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Chronic Fatigue Syndrome (CFS) is often associated with impaired energy metabolism, which can lead to debilitating fatigue. Treatments like oxaloacetate aim to enhance metabolic support and energy production by improving mitochondrial function and reducing oxidative stress. Oxaloacetate, specifically, is involved in the tricarboxylic acid (TCA) cycle, which is crucial for energy production in cells. By supporting the TCA cycle, oxaloacetate can help improve cellular energy levels, potentially alleviating fatigue symptoms in CFS patients. This focus on metabolic support is critical for CFS patients as it directly targets one of the underlying issues contributing to their fatigue, offering a potential pathway to symptom relief and improved quality of life.

Influence of L-carnitine administration on maximal physical exercise.Impact of L-carnitine in narcolepsy treatment: a systematic review on the effectiveness and safety.Sulforaphane exposure impairs contractility and mitochondrial function in three-dimensional engineered heart tissue.