Hydrogen-rich Water and Appetite in Obesity (HYDRAPPET)

January 16, 2025 updated by: Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education

The Effects of 8-week Hydrogen-rich Water Consumption on Body Composition, Appetite and Obesity-specific Quality of Life, and Circulating Glucagon-like Peptide-1 in Obese Men and Women (Hydrappet): a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary aim of this randomized controlled trial is to evaluate the effects of dihydrogen supplementation on body composition indices, appetite, obesity-specific quality of life, and circulating GLP-1 levels in obese men and women

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 26000
        • Applied Bioenergetics Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydrogen-rich water
One liter per day of hydrogen rich water
Dietary supplement: Dietary Supplement: Hydrogen-rich water
Hydrogen-rich water with 12 mg of hydrogen per serving
Placebo Comparator: Control water
One liter per day of tap water
Dietary supplement: Dietary Supplement: Control water
Control water with 0 mg of hydrogen per serving

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite
Time Frame: Change from baseline appetite at 8 weeks
Total scores for appetite as assessed by the the Food Cravings Questionnaire (FCQ)
Change from baseline appetite at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obesity-related quality or life
Time Frame: Change from baseline total scores for obesity-related quality of life at 8 weeks
Total scores for obesity-related quality of life as assessed by the The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire
Change from baseline total scores for obesity-related quality of life at 8 weeks
Body fat
Time Frame: Change from baseline body fat at 8 weeks
Percentage of body fat as assessed by a multifrequency bioelectrical impedance analyzer
Change from baseline body fat at 8 weeks
Serum GLP-1
Time Frame: Change from baseline GLP-1 at 8 weeks
Serum levels of glucagon-like peptide-1 (GLP-1)
Change from baseline GLP-1 at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-HRW-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

Data obtained through this study may be provided to qualified researchers with academic interest in obesity.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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