Controlled Trial of Hydrogen Water as a Treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Part of paid clinical trials in Stony Brook, New York.

Sponsor
Fred Friedberg
Study ID
NCT07753122
Status
Recruiting

Conditions

  • Chronic Fatigue Syndrome (CFS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo condition — DIETARY_SUPPLEMENT
    16 week intervention of magnesium pill without active ingredient of molecular hydrogen.
  • Molecular hydrogen produced by a metallic magnesium tablet, consumed 3x a day dissolved in water. Treatment duration is 16 weeks. — DIETARY_SUPPLEMENT
    The 3 daily doses of molecular hydrogen scheduled for a 16 week intervention. This distinguishes it from the placebo comparator condition.

Study Details

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.

Key Dates

First listed
Aug 7, 2026
Start date
Aug 15, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo condition
    Magnesium tablet, 3 tablets a day dissolved in water, without active ingredient of molecular hydrogen. 16 week duration.
  • Experimental: Active hydrogen water intervention

Primary Outcome Measure

Fatigue Severity Scale [ Time Frame: 2 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stony Brook UniversityStony BrookNew York11794-6000
Fred Friedberg, PhD
5167024213

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