Medium-term Effects of Molecular Hydrogen on Metabolic Fitness in Obesity
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Body fat percentage change
Study Overview
Brief Summary
Molecular hydrogen (H2) effectively tackles obesity-related disorders in animal models yet no studies so far investigated the effectiveness of H2 for improving biomarkers of obesity in humans. In this double blind, placebo-controlled, crossover pilot trial, the investigators will evaluate the effects of H2 intervention on body composition, hormonal status, and mitochondrial function in middle age overweight women, with hydrogen administered orally for 4 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age > 55 years
- •body mass index > 25 kg/m2
Exclusion Criteria
- •no history of H2 supplementation within the 4 weeks before study commenced
- •no major chronic diseases, as evaluated by pre-participation health screening and clinical chemistry
Arms & Interventions
Placebo
Cellulose, tablet, 2 g/day, 4 weeks
Intervention: Placebo (Dietary Supplement)
Molecular hydrogen
Molecular hydrogen, tablet, 2 g/day, 4 weeks
Intervention: Molecular hydrogen (Dietary Supplement)
Outcomes
Primary Outcomes
Body fat percentage change
Time Frame: Baseline vs. four weeks
Baseline vs. four weeks
Secondary Outcomes
- Serum insulin change in IU/mL(Baseline vs. four weeks)
Investigators
Assoc. Prof. Sergej M. Ostojic, MD, PhD
Principal Investigator
Center for Health, Exercise and Sport Sciences, Serbia