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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02832219
Other study ID # 16-AD
Secondary ID
Status Completed
Phase Phase 3
First received July 5, 2016
Last updated July 11, 2016
Start date January 2016
Est. completion date May 2016

Study information

Verified date July 2016
Source Center for Health, Exercise and Sport Sciences, Serbia
Contact n/a
Is FDA regulated No
Health authority Serbia: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date May 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 55 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Molecular hydrogen

Placebo


Locations

Country Name City State
Serbia Center for Health, Exercise and Sport Sciences Belgrade

Sponsors (1)

Lead Sponsor Collaborator
Center for Health, Exercise and Sport Sciences, Serbia

Country where clinical trial is conducted

Serbia, 

References & Publications (2)

Huang CS, Kawamura T, Toyoda Y, Nakao A. Recent advances in hydrogen research as a therapeutic medical gas. Free Radic Res. 2010 Sep;44(9):971-82. doi: 10.3109/10715762.2010.500328. Review. — View Citation

Ostojic SM. Molecular hydrogen: An inert gas turns clinically effective. Ann Med. 2015 Jun;47(4):301-4. doi: 10.3109/07853890.2015.1034765. Epub 2015 May 4. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Serum ghrelin change in IU/mL Baseline vs. four weeks Baseline vs. four weeks No
Primary Body fat percentage change Baseline vs. four weeks Baseline vs. four weeks No
Secondary Serum insulin change in IU/mL Baseline vs. four weeks Baseline vs. four weeks No
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