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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 August 2016
Main ID:  NCT02832219
Date of registration: 05/07/2016
Prospective Registration: No
Primary sponsor: Center for Health, Exercise and Sport Sciences, Serbia
Public title: Medium-term Effects of Molecular Hydrogen on Metabolic Fitness in Obesity
Scientific title: Medium-term Effects of Molecular Hydrogen on Metabolic Fitness in Obesity
Date of first enrolment: January 2016
Target sample size: 12
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02832219
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)  
Phase:  Phase 3
Countries of recruitment
Serbia
Contacts
Key inclusion & exclusion criteria

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



Age minimum: 55 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Obesity
Intervention(s)
Dietary Supplement: Placebo
Dietary Supplement: Molecular hydrogen
Primary Outcome(s)
Body fat percentage change [Time Frame: Baseline vs. four weeks]
Secondary Outcome(s)
Serum insulin change in IU/mL [Time Frame: Baseline vs. four weeks]
Secondary ID(s)
16-AD
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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