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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02832219
First Posted: July 14, 2016
Last Update Posted: July 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences, Serbia
  Purpose
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 Intervention Phase
Obesity Dietary Supplement: Molecular hydrogen Dietary Supplement: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences, Serbia:

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


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


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


Enrollment: 12
Study Start Date: January 2016
Study Completion Date: May 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
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
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
Serbia
Center for Health, Exercise and Sport Sciences
Belgrade, Serbia, 11000
Sponsors and Collaborators
Center for Health, Exercise and Sport Sciences, Serbia
  More Information

Publications:
Responsible Party: Assoc. Prof. Sergej M. Ostojic, MD, PhD, Principal Investigator, Center for Health, Exercise and Sport Sciences, Serbia
ClinicalTrials.gov Identifier: NCT02832219     History of Changes
Other Study ID Numbers: 16-AD
First Submitted: July 5, 2016
First Posted: July 14, 2016
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:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms