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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832219
• Other study ID #: 16-AD
• 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

• Obesity

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