NCT06722326

Brief Summary

The main goal of this study is to investigate how dihydrogen supplementation impacts body composition, appetite, quality of life specific to obesity, and levels of the hormone GLP-1 in men and women with obesity. This randomized controlled trial aims to explore whether dihydrogen can improve these health indicators.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable 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

May 15, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

December 3, 2024

Last Update Submit

January 16, 2025

Conditions

Obesity

Keywords

dihydrogenappetiteLDL cholesterolsupplementation

Outcome Measures

Primary Outcomes (1)

  • Appetite

    Total scores for appetite as assessed by the the Food Cravings Questionnaire (FCQ)

    Change from baseline appetite at 8 weeks

Secondary Outcomes (3)

  • Obesity-related quality or life

    Change from baseline total scores for obesity-related quality of life at 8 weeks

  • Body fat

    Change from baseline body fat at 8 weeks

  • Serum GLP-1

    Change from baseline GLP-1 at 8 weeks

Study Arms (2)

Hydrogen-rich water

EXPERIMENTAL

One liter per day of hydrogen rich water

Dietary Supplement: Dietary Supplement: Hydrogen-rich water

Control water

PLACEBO COMPARATOR

One liter per day of tap water

Dietary Supplement: Dietary Supplement: Control water

Interventions

Dietary Supplement: Hydrogen-rich waterDIETARY_SUPPLEMENT

Hydrogen-rich water with 12 mg of hydrogen per serving

Hydrogen-rich water
Dietary Supplement: Control waterDIETARY_SUPPLEMENT

Control water with 0 mg of hydrogen per serving

Control water

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years
  • Body fat \> 30% in women and \> 25% in men
  • Not physically active
  • Informed consent signed

You may not qualify if:

  • Major chronic disease and acute injuries
  • History of dietary supplement use during the past 4 weeks
  • History of obesity pharmaceuticals use during the past 8 weeks
  • No consent to randomization
  • Participation in other studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Bioenergetics Lab

Novi Sad, Vojvodina, 26000, Serbia

Location

Related Publications (2)

  • Korovljev D, Ostojic J, Todorovic N, Ostojic SM. Molecular hydrogen modulates brain glutamate/GABA-glutamine cycle in overweight humans. Arch Med Sci. 2023 Jul 13;19(4):1151-1153. doi: 10.5114/aoms/162938. eCollection 2023.

    PMID: 37560746BACKGROUND

  • Todorovic N, Baltic S, Nedeljkovic D, Kuzmanovic J, Korovljev D, Javorac D, Bijelic K, Kladar N, Tarnava A, Ostojic SM. The Effects of 8-Week Hydrogen-Rich Water Consumption on Appetite, Body Composition, Sleep Quality, and Circulating Glucagon-like Peptide-1 in Obese Men and Women (HYDRAPPET): A Randomized Controlled Trial. Medicina (Kaunas). 2025 Jul 18;61(7):1299. doi: 10.3390/medicina61071299.

    PMID: 40731927DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head of the Lab

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 9, 2024

Study Start

May 15, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Data obtained through this study may be provided to qualified researchers with academic interest in obesity. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access Criteria
Data obtained through this study may be provided to qualified researchers with academic interest in obesity.

Locations

SE(1)