Hydrogen Water Intervention With Heart Rate Variability as an Outcome Biomarker in ME/CFS

Last updated: June 3, 2025
Sponsor: Stony Brook University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Fatigue Syndrome

Fibromyalgia

Pain (Pediatric)

Treatment

Hydrogen water which is prepared from an OTC supplement.

Clinical Study ID

NCT07009691
IRB2025-00017
  • Ages 18-65
  • All Genders

Study Summary

The goal of this clinical trial is to learn if the OTC supplement, hydrogen water, works to treat the fatigue-related symptoms and functional limitations in adults with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). It will also examine if heart rate variability (HRV) can be used to predict who will benefit from the hydrogen water treatment. The main questions it aims to answer are:

Does the OTC supplement, hydrogen water, work to reduce the fatigue-related symptoms and improve functioning in participants who have ME/CFS?

Can HRV be used to predict who will benefit from treatment with hydrogen water?

Eligibility Criteria

Inclusion

Inclusion Criteria: Meets Institute of Medicine criteria for myalgic encephalomyelitis/chronic fatigue syndrome -

Exclusion

Exclusion Criteria: Medical illness that explains presenting fatigue; Any psychosis.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Hydrogen water which is prepared from an OTC supplement.
Phase:
Study Start date:
June 09, 2025
Estimated Completion Date:
May 31, 2026

Study Description

The purpose of this pilot study is to identify a biomarker for improvement in chronic fatigue syndrome. Treatment of ME/CFS starting on 10-day graduated dosing schedule followed by a standard daily dose of hydrogen water (a magnesium-based OTC supplement) over 16 weeks is expected to yield two subgroups, improvers and non-improvers. These subgroups will be delineated by heart rate variability (HRV), a biological measure of health and well-being. Higher HRV will predict improvement and lower HRV will predict non-improvement (no change or worsening). This would be the first biomarker of improvement found in ME/CFS. If treatment is successful, subjects will experience a reduction in fatigue and an increase in physical function. Thus, the study may advance potentially an effective intervention for individuals with ME/CFS and further the understanding of the biology of favorable treatment outcomes, i.e., improved HRV status.

Connect with a study center

  • Stony Brook University

    Stony Brook, New York 11794-8101
    United States

    Active - Recruiting

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