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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Molecular hydrogen

Molecular hydrogen, tablet, 2 g/day, 4 weeks

Group Type EXPERIMENTAL

Molecular hydrogen

Intervention Type DIETARY_SUPPLEMENT

Placebo

Cellulose, tablet, 2 g/day, 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Molecular hydrogen

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes