Hydrogen Water for Chronic Fatigue Syndrome

Overseen By Fred Friedberg, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stony Brook University

Disqualifiers: Medical illness, Psychosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether hydrogen water, an over-the-counter supplement known for its strong antioxidant properties, can reduce tiredness and improve daily activities in people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Researchers aim to determine if heart rate variability (HRV), which measures how heart rate changes with activity, can predict who will benefit from the treatment. Individuals diagnosed with ME/CFS who experience ongoing fatigue that disrupts daily life might be suitable candidates for this trial. As an unphased trial, this study provides an opportunity to contribute to understanding potential new treatments for ME/CFS.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that hydrogen water is safe for humans?

Research has shown that hydrogen water is generally safe to use. Studies involving individuals with chronic fatigue syndrome found that drinking hydrogen water is safe and has few side effects. For instance, when participants drank hydrogen water for several weeks, no major safety issues were reported.

Animal studies have also shown positive results. In these studies, hydrogen water reduced tiredness in stressed mice and rats without causing harm. This suggests that hydrogen water might be safe for humans as well.

However, it is important to consult a healthcare provider before starting any new treatment, even if hydrogen water appears safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hydrogen water for chronic fatigue syndrome because it introduces a new mechanism of action as a strong antioxidant. Unlike standard treatments for chronic fatigue syndrome, which often rely on managing symptoms through medication and lifestyle changes, hydrogen water targets oxidative stress, a potential underlying cause of fatigue. This innovative approach could provide relief by directly addressing the root of the problem rather than just alleviating symptoms. Additionally, as an over-the-counter supplement, hydrogen water might offer a more accessible and convenient option for patients.

What evidence suggests that hydrogen water might be an effective treatment for chronic fatigue syndrome?

Research has shown that hydrogen water, which participants in this trial will receive, might help alleviate symptoms of chronic fatigue syndrome (CFS). Some studies suggest that hydrogen, a powerful antioxidant, can reduce tiredness and enhance physical abilities in people with CFS. Evidence also indicates that hydrogen water may lower stress levels, potentially aiding in CFS management. However, while these early findings are promising, further research is needed to confirm the effectiveness of hydrogen water for CFS. ^{1 2 3 6 7}

Who Is on the Research Team?

Fred Friedberg, PhD

Principal Investigator

Stony Brook University

Are You a Good Fit for This Trial?

This trial is for adults with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) who are interested in trying hydrogen water, an over-the-counter supplement, to alleviate their fatigue-related symptoms. The study will also explore if heart rate variability can indicate the likelihood of benefit from this treatment.

Inclusion Criteria

Meets Institute of Medicine criteria for myalgic encephalomyelitis/chronic fatigue syndrome

Exclusion Criteria

Any psychosis

I have a medical condition that causes my fatigue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hydrogen water treatment starting with a 10-day graduated dosing schedule followed by a standard daily dose over 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Hydrogen Water

Trial Overview

The clinical trial is testing whether drinking hydrogen water can reduce fatigue and improve daily functioning in ME/CFS patients. It's also investigating if monitoring heart rate variability helps predict the effectiveness of hydrogen water for these individuals.

How Is the Trial Designed?

Group I: Hydrogen water standard dosage Experimental Treatment 1 Intervention

The intervention is hydrogen water which is prepared from an OTC supplement. Hydrogen water is a strong anti-oxidant.

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9042428/

Molecular Hydrogen as a Medical Gas for the Treatment of ...

Our literature review suggested that H 2 gas may be an effective medical gas for the treatment of ME/CFS.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06227273

NCT06227273 | Hydrogen Water Dosing Study for ME/CFS

Outcomes measures will include online assessments of fatigue, physical function and stress. A salivary biomarker for oxidative stress, Uric Acid, will also be ...

3.

tandfonline.com

tandfonline.com/doi/full/10.1080/21641846.2025.2504211?af=R

Hydrogen water and heart rate variability biofeedback as ...

Hydrogen water as a treatment for myalgic encephalomyelitis/ chronic fatigue syndrome: a pilot randomized trial. Fatigue: Biomed Health Behavio. Published ...

4.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT07009691/hydrogen-water-intervention-with-heart-rate-variability-as-an-outcome-biomarker-in-me-cfs

Hydrogen Water Intervention With Heart Rate Variability as ...

If treatment is successful, subjects will experience a reduction in fatigue and an increase in physical function. Thus, the study may advance ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10715329/

Successful treatment of myalgic encephalomyelitis/chronic ...

The results obtained suggest the potential of H 2 gas as a therapeutic gas for ME/CFS. Further large-scale clinical studies are needed to evaluate the efficacy.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10816294/

Hydrogen Water: Extra Healthy or a Hoax?—A Systematic ...

The use of HD solutions with electrolyzed hydrogen-rich water decreased fatigue in patients on both HD and even on HD-free days [25]. Alkaline-electrolyzed- ...

7.

trials.arthritis.org

trials.arthritis.org/trials/NCT05397626

Biofeedback and Hydrogen Water as Treatments for Chronic ...

The treatment lasts 8 weeks. ... Hydrogen pills are mixed in a water glass that is ingested up to 3 times a day for 8 weeks. The hydrogen supplement is intended ...