NCT07753122 · Fred Friedberg
Controlled Trial of Hydrogen Water as a Treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
(ME/CFS)
What this study is about
This is a 16-week controlled treatment trial of an over-the -counter supplement, hydrogen water, for individuals with ME/CFS patients. An active treatment condition will be compared to a placebo-control condition. The study will also seek confirmation of heart rate variability (HRV) as a biomarker, that is, as a predictor of improvement vs. non-improvement to be assessed at treatment termination.
View original scientific description
This is a 16-week controlled treatment trial of an over-the -counter supplement, hydrogen water, for individuals with ME/CFS patients. An active treatment condition will be compared to a placebo-control condition. The study will also seek confirmation of heart rate variability (HRV) as a biomarker, that is, as a predictor of improvement vs. non-improvement to be assessed at treatment termination. The HRV biomarker hypothesis is based on a finding that High Frequency HRV (cardio-parasympathetic measure) biologically separated improvers and non-improvers in my previous ME/CFS observational study.
Interventions
DIETARY_SUPPLEMENT
Placebo condition
16 week intervention of magnesium pill without active ingredient of molecular hydrogen.
DIETARY_SUPPLEMENT
Molecular hydrogen produced by a metallic magnesium tablet, consumed 3x a day dissolved in water. Treatment duration is 16 weeks.
The 3 daily doses of molecular hydrogen scheduled for a 16 week intervention. This distinguishes it from the placebo comparator condition.
Primary outcome measures
Fatigue Severity Scale
Time frame: 2 weeks.
Self-report measure of the effect of fatigue on functioning.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients aged 18-65 of both sexes
- considered physically capable and willing to perform the study tasks
- Meet validated phone-screen eligibility for ME/CFS criteria
- Participant has internet and computer
Exclusion criteria
- Cases of fatigue clearly attributable to self-report medical conditions such as untreated hypothyroidism, unstable diabetes mellitus, organ failure, chronic infections, and chronic inflammatory diseases, or AIDS. Kidney disease/renal failure is also an exclusion
- Pregnancy is an exclusion.
- Patients with BMI\>35 \_\_\_\_Patients regularly taking therapeutic magnesium.
- Patients at significant risk of suicide or in need of urgent psychiatric treatment. As much as possible, appropriate medical and psychiatric referrals to facilities local to subjects will be provided.
Where
- Stony Brook, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2026 · Source of record for eligibility and locations