Recruiting

Hydrogen Water

Sponsor:

Fred Friedberg

Code:

NCT07753122

Conditions

Chronic Fatigue Syndrome (CFS)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Placebo condition

Molecular hydrogen produced by a metallic magnesium tablet, consumed 3x a day dissolved in water. Treatment duration is 16 weeks.

Study Details

Brief summary:

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.

Conditions

Chronic Fatigue Syndrome (CFS)

Study ID

NCT07753122

Start date

Aug 15, 2026

Status verified date

Jun, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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
  • Exclusionary psychiatric disorders include any psychosis, or alcohol/ substance abuse within two years prior to illness onset and any time afterward, and current or past depression with melancholic or psychotic features within 5 years prior to onset of ME/CFS or anytime afterward

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Placebo condition

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.

The 3 daily doses of molecular hydrogen scheduled for a 16 week intervention. This distinguishes it from the placebo comparator condition.

Primary outcome measure

  • Fatigue Severity Scale [ Time Frame: 2 weeks. ]

Central Contacts and Locations

Central contacts

Fred Friedberg, PhD

16316381931Fred.Friedberg@stonybrookmedicine.edu

Locations

Stony Brook University

Recruiting

Stony Brook, New York, United States, 11794-6000

Contacts

Fred Friedberg, PhD

5167024213ffriedberg12@gmail.com

More Information

Sponsor

Fred Friedberg

Last update posted

Aug 7, 2026

Last verified

Jun, 2026

Keywords

  • chronic fatigue syndrome; myalgic encephelomyelitis; ME/CFS; hydrogen water; treatment; biomarker heart rate variability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Fred Friedberg on 2026-08-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.