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NCT Number: NCT07009691

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

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?

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Key information

Conditions

Chronic Fatigue Syndrome Chronic Disease Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University

Stony Brook, New York, 11794-8101, United States

Location status: Recruiting

Location contact

Fred Friedberg, PhD

CONTACT

[email protected]

Fred Friedberg, PhD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Medical illness that explains presenting fatigue; Any psychosis.

-

Treatment and study plan

Hydrogen water which is prepared from an OTC supplement.

Dietary Supplement

The intervention is hydrogen water which is prepared from an OTC supplement. It involves measurement of heart rate variability.

Primary outcomes

  1. Fatigue Severity Scale

    Time frame: 12 months

    This is a validated self-report measure of the effect of fatigue on functioning.

Study contacts

Contact information is provided by the study sponsor or research team.

Fred Friedberg, PhD

CONTACT

[email protected]

15167024213

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study title

Heart Rate Variability as an Autonomic Marker of Improvement in ME/CFS in a Hydrogen Water Treatment Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2025
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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