Hydrogen Water Intervention With Heart Rate Variability as an Outcome Biomarker in ME/CFS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hydrogen water which is prepared from an OTC supplement..
- Who it may be relevant to
- Registry conditions: Chronic Fatigue Syndrome. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Heart Rate Variability as an Autonomic Marker of Improvement in ME/CFS in a Hydrogen Water Treatment Study
Overview
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?
Detailed 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.
Interventions
- Dietary supplement Hydrogen water which is prepared from an OTC supplement.
The intervention is hydrogen water which is prepared from an OTC supplement. It involves measurement of heart rate variability.
Primary outcome measures
- Fatigue Severity Scale [Time frame: 12 months]
Eligibility criteria
Inclusion Criteria: Meets Institute of Medicine criteria for myalgic encephalomyelitis/chronic fatigue syndrome -
Exclusion Criteria: Medical illness that explains presenting fatigue; Any psychosis.
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stony Brook University — Stony Brook
Identifiers
NCT: NCT07009691 · IRB2025-00017