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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrogen water standard dosage | Experimental | The intervention is hydrogen water which is prepared from an OTC supplement. Hydrogen water is a strong anti-oxidant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogen water which is prepared from an OTC supplement. | Dietary Supplement | The intervention is hydrogen water which is prepared from an OTC supplement. It involves measurement of heart rate variability. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Severity Scale | This is a validated self-report measure of the effect of fatigue on functioning. | 12 months |
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Inclusion Criteria: Meets Institute of Medicine criteria for myalgic encephalomyelitis/chronic fatigue syndrome -
Exclusion Criteria: Medical illness that explains presenting fatigue; Any psychosis.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fred Friedberg, PhD | Contact | 15167024213 | fred.friedberg@stonybrookmedicine.edu |
| Name | Affiliation | Role |
|---|---|---|
| Fred Friedberg, PhD | Stony Brook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University | Recruiting | Stony Brook | New York | 11794-8101 | United States |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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This is a study of hydrogen water as an intervention for ME/CFS that includes heart rate variability as a potential outcome marker of improvement/non-improvement.
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| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |