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OpenTrials
Completed

NCT Number: NCT02832219

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

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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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Center for Health, Exercise and Sport Sciences

Belgrade, Serbia, 11000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Molecular hydrogen

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Body fat percentage change

    Time frame: Baseline vs. four weeks

    Baseline vs. four weeks

Secondary outcomes

  1. Serum insulin change in IU/mL

    Time frame: Baseline vs. four weeks

    Baseline vs. four weeks

Other outcomes

  1. Serum ghrelin change in IU/mL

    Time frame: Baseline vs. four weeks

    Baseline vs. four weeks

Sponsors and collaborators

Lead sponsor

Center for Health Sciences, Serbia

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 14, 2016
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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