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.
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
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
Parallel
Placebo condition
Dietary supplement16 week intervention of magnesium pill without active ingredient of molecular hydrogen.
Molecular hydrogen produced by a metallic magnesium tablet, consumed 3x a day dissolved in water. Treatment duration is 16 weeks.
Dietary supplementThe 3 daily doses of molecular hydrogen scheduled for a 16 week intervention. This distinguishes it from the placebo comparator condition.
Fatigue Severity Scale
Self-report measure of the effect of fatigue on functioning.
SF-36 Physical Function Subscale
Self-report measure of how much health limits your ability to perform various types of physical activities.
Depression, Anxiety and Stress Scale
Self-report measures three related negative emotional states of depression, anxiety, and tension/stress.
Hassles and Uplifts Scale
Self-report measure of chronic minor stressors and positive everyday experiences.
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Fred Friedberg
Lead sponsor
Stony Brook University
Sponsor institution
