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

Stony Brook University

Status: Enrolling

Conditions: Chronic Fatigue Syndrome

Treatments: Dietary Supplement: Hydrogen water which is prepared from an OTC supplement.

Study type: Interventional

Funder types: Other

Identifiers

NCT07009691

IRB2025-00017

Details and patient eligibility

About

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?

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Hydrogen water standard dosage

Experimental group

Description:

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

Treatment:

Dietary Supplement: Hydrogen water which is prepared from an OTC supplement.