Chronic Fatigue Syndrome (CFS)
Conditions
Keywords
chronic fatigue syndrome; myalgic encephelomyelitis; ME/CFS; hydrogen water; treatment; biomarker heart rate variability
Brief summary
This is a 16-week controlled treatment trial of an over-the -counter supplement, hydrogen water, for individuals with ME/CFS patients. An active treatment condition will be compared to a placebo-control condition. The study will also seek confirmation of heart rate variability (HRV) as a biomarker, that is, as a predictor of improvement vs. non-improvement to be assessed at treatment termination. The HRV biomarker hypothesis is based on a finding that High Frequency HRV (cardio-parasympathetic measure) biologically separated improvers and non-improvers in my previous ME/CFS observational study.
Detailed description
The purpose of this pilot randomized controlled trial is (1) to more definitively test for the efficacy of hydrogen water as a treatment for chronic fatigue syndrome (CFS) and (2) identify and confirm a cardio-autonomic biomarker for improvement in chronic fatigue syndrome. Treatment of chronic fatigue syndrome will start with a 10-day graduated dosing schedule followed by a standard daily dose of hydrogen water (a magnesium-based OTC supplement) over 16 weeks. We expect the active treatment condition to show significant improvements in fatigue and physical function in comparison to the placebo control condition. The treatment outcomes will also be examined for the presence of 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 chronic fatigue syndrome. 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 CFS and further the understanding of the biology of favorable treatment outcomes, i.e., improved HRV status.
Interventions
DIETARY_SUPPLEMENTPlacebo condition
16 week intervention of magnesium pill without active ingredient of molecular hydrogen.
DIETARY_SUPPLEMENTMolecular hydrogen produced by a metallic magnesium tablet, consumed 3x a day dissolved in water. Treatment duration is 16 weeks.
The 3 daily doses of molecular hydrogen scheduled for a 16 week intervention. This distinguishes it from the placebo comparator condition.
Sponsors
Fred Friedberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18-65 of both sexes * considered physically capable and willing to perform the study tasks * Meet validated phone-screen eligibility for ME/CFS criteria * Participant 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. Kidney disease/renal failure is also an exclusion * 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 regularly taking therapeutic magnesium. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity Scale | 2 weeks. | Self-report measure of the effect of fatigue on functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 Physical Function Subscale | 30 days | Self-report measure of how much health limits your ability to perform various types of physical activities. |
| Depression, Anxiety and Stress Scale | 30 days | Self-report measures three related negative emotional states of depression, anxiety, and tension/stress. |
| Hassles and Uplifts Scale | 2 weeks | Self-report measure of chronic minor stressors and positive everyday experiences. |
Countries
United States
Contacts
CONTACTFred Friedberg, PhD
PRINCIPAL_INVESTIGATORFred Friedberg, PhD
Stony Brook University
Outcome results
None listed