NCT02832219

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_3 obesity

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_3 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

3 months

First QC Date

July 5, 2016

Last Update Submit

July 11, 2016

Conditions

Obesity

Keywords

OverweightMolecular hydrogenInsulin

Outcome Measures

Primary Outcomes (1)

  • Body fat percentage change

    Baseline vs. four weeks

    Baseline vs. four weeks

Secondary Outcomes (1)

  • Serum insulin change in IU/mL

    Baseline vs. four weeks

Other Outcomes (1)

  • Serum ghrelin change in IU/mL

    Baseline vs. four weeks

Study Arms (2)

Molecular hydrogen

EXPERIMENTAL

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

Dietary Supplement: Molecular hydrogen

Placebo

PLACEBO COMPARATOR

Cellulose, tablet, 2 g/day, 4 weeks

Dietary Supplement: Placebo

Interventions

Molecular hydrogenDIETARY_SUPPLEMENT
Molecular hydrogen
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age55 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 55 years
  • body mass index \> 25 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health, Exercise and Sport Sciences

Belgrade, Serbia, 11000, Serbia

Location

Related Publications (3)

  • 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.

    PMID: 25936365BACKGROUND

  • 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.

    PMID: 20815764BACKGROUND

  • Korovljev D, Trivic T, Drid P, Ostojic SM. Molecular hydrogen affects body composition, metabolic profiles, and mitochondrial function in middle-aged overweight women. Ir J Med Sci. 2018 Feb;187(1):85-89. doi: 10.1007/s11845-017-1638-4. Epub 2017 May 30.

    PMID: 28560519DERIVED

MeSH Terms

Conditions

ObesityOverweightInsulin Resistance

Interventions

Hydrogen

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

ElementsInorganic ChemicalsGases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 14, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

July 14, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)