NCT07009691

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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?

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.

Conditions

• Chronic Fatigue Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-09
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2025-06-08
• Last updated: 2025-06-08

Locations

1 site across 1 country: United States