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

Study Purpose

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?

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07009691
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Stony Brook University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Fred Friedberg, PhD
Principal Investigator Affiliation	Stony Brook University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Fatigue Syndrome

Additional Details

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.

Arms & Interventions

Arms

Experimental: Hydrogen water standard dosage

The intervention is hydrogen water which is prepared from an OTC supplement. Hydrogen water is a strong anti-oxidant.

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.

Contact a Trial Team

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Stony Brook University, Stony Brook, New York

Status

Recruiting

Address

Stony Brook University

Stony Brook, New York, 11794-8101

Site Contact

Fred Friedberg, PhD

[email protected]

15167024213

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