Myalgic Encephalomyelitis/Chronic Fatigue SyndromeNCT06227273
Hydrogen Water Dosing Study for ME/CFS
A study testing Hydrogen water in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, run by Stony Brook University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- What is being tested?
- Hydrogen water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Fred Friedberg
Stony Brook, New York, 11794
FRED FRIEDBERG, PhD, 631-638-1931, fred.friedberg@stonybrookmedicine.edu
Fred Friedberg, PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- Hydrogen water
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen waterDietary supplement
Daily consumption of hydrogen water for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| H2 Standard Dose | Active comparator | This condition will schedule 1-5 glasses of hydrogen water a day for 16 weeks. Receives: Dietary Supplement: Hydrogen water |
| H2 Standard Dose followed by Higher Dose H2 | Active comparator | 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. Receives: Dietary Supplement: Hydrogen water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale
Self-report measure of effect of fatigue on functioning.
Measured: 16 weeks
Secondary outcomes (2)
SF-36 PF
Self-report physical function measure
Measured: 16 weeks
Depression, Anxiety and Stress Scale
Self-report measure of depression, anxiety and stress symptoms
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Dec 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myalgic Encephalomyelitis/Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two different 16-week dosing schedules will be compared: A standard dose of hydrogen water as compared to a standard dose followed by an increased dose of hydrogen water.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Wellness Now Health Products
- Responsible party
- Principal investigator, Fred Friedberg, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227273
- Sponsor's protocol ID
- 41245
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrogen Water Dosing Study for ME/CFS and Chronic Fatigue
- ClinicalTrials.gov ID
- NCT06227273
- Acronym / sponsor ID
- 41245
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Natural Wellness Now Health Products
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Two different 16-week dosing schedules will be compared: A standard dose of hydrogen water as compared to a standard dose followed by an increased dose of hydrogen water.
| Arm | Type | Receives |
|---|---|---|
| H2 Standard Dose | Active comparator | Dietary Supplement: Hydrogen waterThis condition will schedule 1-5 glasses of hydrogen water a day for 16 weeks. |
| H2 Standard Dose followed by Higher Dose H2 | Active comparator | Dietary Supplement: Hydrogen waterThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen waterDaily consumption of hydrogen water for 16 weeks. | Dietary supplement | H2 Standard Dose, H2 Standard Dose followed by Higher Dose H2 |
Primary outcome
Fatigue Severity Scale
Time frame: 16 weeks
Self-report measure of effect of fatigue on functioning.
2 secondary outcomes
SF-36 PF
Time frame: 16 weeks
Depression, Anxiety and Stress Scale
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen water in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fred Friedberg, PhD (631-638-1931, fred.friedberg@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.