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

NCT ID: NCT07009691

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-09
• Study Completion Date: 2026-05-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydrogen water standard dosage

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

Group Type: EXPERIMENTAL

Hydrogen water which is prepared from an OTC supplement.

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Fred Friedberg

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fred Friedberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Fred Friedberg, PhD

Role: CONTACT

fred.friedberg@stonybrookmedicine.edu

15167024213

Facility Contacts

Fred Friedberg, PhD

Role: primary

fred.friedberg@stonybrookmedicine.edu

Role: backup

fred.friedberg@stonybrookmedicine.edu

Other Identifiers

IRB2025-00017

Identifier Type: -

Identifier Source: org_study_id