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Medium-term Effects of Molecular Hydrogen on Metabolic Fitness in Obesity

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ClinicalTrials.gov Identifier: NCT02832219
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences, Serbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Molecular hydrogen Dietary Supplement: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Medium-term Effects of Molecular Hydrogen on Metabolic Fitness in Obesity
Study Start Date : January 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Molecular hydrogen
Molecular hydrogen, tablet, 2 g/day, 4 weeks
 Dietary Supplement: Molecular hydrogen
Placebo Comparator: Placebo
Cellulose, tablet, 2 g/day, 4 weeks
 Dietary Supplement: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Body fat percentage change [ Time Frame: Baseline vs. four weeks ]
    Baseline vs. four weeks


Secondary Outcome Measures :
  1. Serum insulin change in IU/mL [ Time Frame: Baseline vs. four weeks ]
    Baseline vs. four weeks


Other Outcome Measures:
  1. Serum ghrelin change in IU/mL [ Time Frame: Baseline vs. four weeks ]
    Baseline vs. four weeks


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832219


Locations
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Serbia
Center for Health, Exercise and Sport Sciences
Belgrade, Serbia, 11000
Sponsors and Collaborators
Center for Health, Exercise and Sport Sciences, Serbia
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assoc. Prof. Sergej M. Ostojic, MD, PhD, Principal Investigator, Center for Health, Exercise and Sport Sciences, Serbia
ClinicalTrials.gov Identifier: NCT02832219    
Other Study ID Numbers: 16-AD
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences, Serbia:
Overweight
Molecular hydrogen
Insulin
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight