Hydrogen Water Dosing Study for ME/CFS

Hydrogen Water Dosing Study for ME/CFS and Chronic Fatigue

The aim of this 16-week pilot randomized trial is to explore the potential benefit of the OTC supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Methods: This 16-week home-based trial will compare two groups: (1) low dose hydrogen water (2-3 glasses/day) for all 16 weeks; and (2) low dose followed by high dose hydrogen water (up to 5 glasses/day). Condition (2) involves an initial 8 weeks of low dose H2 followed by 8 weeks of high dose H2 in order to test the premise that the higher dosage will be more effective with fewer adverse effects if preceded by several weeks of low dose H2. Outcomes measures will include online assessments of fatigue, physical function and stress. A salivary biomarker for oxidative stress, Uric Acid, will also be assessed.

Study Overview

• Status: Recruiting
• Conditions: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
• Intervention / Treatment: Dietary supplement: Hydrogen water

Detailed Description

Previous clinical studies (8-12 week intervention trials) have indicated that H2 enriched water reduces concentrations of markers of oxidative stress in patients with metabolic syndrome, improves lipid and glucose metabolism in patients with type 2 diabetes, improves mitochondrial dysfunction in patients with mitochondrial myopathies, and reduces inflammatory processes in patients with polymyositis/ dermatomyositis (Mizuno et al., 2017). In addition to its potential therapeutic properties, H2 water is portable, easily administered and safe to ingest (Nagata et al., 2013). Owing to its potential therapeutic efficacy and lack of adverse effects, H2 may show promise for clinical use in ME/CFS. Two CFS studies conducted in the PI's laboratory (Friedberg and Choi, 2022; Friedberg and Choi, under review) yielded mixed findings. The initial randomized controlled trial showed no benefit for H2 water, but the second study, a randomized trial of H2 and heart rhythm biofeedback that was of longer duration (60 days) with a lower dosage of H2 water found significant improvements in fatigue and physical function. The new proposed randomized trial will extend treatment to 120 days and test a standard dosage of H2 water for all 120 days in group1 in comparison to standard dosage for the initial 60 days followed by increased dosage for the remaining 60 days (Group 2). Group 2 is may show a greater treatment effect once subjects are acclimated to the lower initial dose. Thus, we are testing different dosing schedules to determine which may be more effective in CFS.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: FRED FRIEDBERG, PhD; Phone Number: 631-638-1931; Email: fred.friedberg@stonybrookmedicine.edu

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Fred Friedberg
      • Contact: FRED FRIEDBERG, PhD; Phone Number: 631-638-1931; Email: fred.friedberg@stonybrookmedicine.edu
      • Principal Investigator: Fred Friedberg, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Patients aged 18-65 of both sexes; considered physically capable and willing to perform the study tasks.

• Meeting validated phone-screen eligibility for ME/CFS criteria.
• Patient has internet and computer.

Exclusion Criteria:

Cases of fatigue clearly attributable to self-report medical conditions such as untreated hypothyroidism, unstable diabetes mellitus, organ failure, chronic infections, and chronic inflammatory diseases, or AIDS.

__ Exclusionary psychiatric disorders include any psychosis, or alcohol/ substance abuse within two years prior to illness onset and any time afterward, and current or past depression with melancholic or psychotic features within 5 years prior to onset of ME/CFS or anytime afterward

• Pregnancy is an exclusion.
• Patients with BMI>35.
• Patients at significant risk of suicide or in need of urgent psychiatric treatment. As much as possible, appropriate medical and psychiatric referrals to facilities local to subjects will be provided.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: H2 Standard Dose; This condition will schedule 1-5 glasses of hydrogen water a day for 16 weeks.	Dietary supplement: Hydrogen water; Daily consumption of hydrogen water for 16 weeks.
Active Comparator: H2 Standard Dose followed by Higher Dose H2; This condition will schedule 1-5 glasses of hydrogen water a day for 8 weeks followed by 4-5 glasses of hydrogen water for 8 weeks.	Dietary supplement: Hydrogen water; Daily consumption of hydrogen water for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Severity Scale	Self-report measure of effect of fatigue on functioning.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36 PF	Self-report physical function measure	16 weeks
Depression, Anxiety and Stress Scale	Self-report measure of depression, anxiety and stress symptoms	16 weeks

Collaborators and Investigators

• Sponsor: Stony Brook University
• Collaborators: Natural Wellness Now Health Products

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Central Nervous System Infections; Neuroinflammatory Diseases; Fatigue; Fatigue Syndrome, Chronic; Encephalomyelitis
• Other Study ID Numbers: 41245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No