Hydrogen Water Dosing Study for ME/CFS
Sponsor
Stony Brook University
Information provided by Fred Friedberg, Stony Brook University
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.
ClinicalTrials.gov ID: NCT06227273
Sponsor
Stony Brook University
Information provided by Fred Friedberg, Stony Brook University
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.
ClinicalTrials.gov ID: NCT06227273
