Supersaturated Hydrogen-Rich Water for Outpatients With Persistent Excess Weight (HOPE)

February 7, 2026 updated by: Center for Health Sciences, Serbia

Supersaturated Hydrogen-Rich Water for Outpatients With Persistent Excess Weight (HOPE)

The Supersaturated Hydrogen-Rich Water for Outpatients with Persistent Excess Weight (HOPE) study is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of daily consumption of supersaturated hydrogen-rich water in adults with persistent excess body weight. The trial investigates whether sustained exposure to molecular hydrogen can favorably influence body composition and key metabolic outcomes compared with a placebo water lacking dissolved hydrogen. By enrolling outpatients across multiple centers and applying rigorous blinding and randomization procedures, HOPE aims to generate high-quality clinical evidence on the potential role of hydrogen-rich water as a non-pharmacological, adjunctive strategy for weight management and metabolic health.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

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 Contact

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Center for Health Sciences

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

Yes

Description

Inclusion Criteria:

  • Age > 18 years
  • Body mass index > 25.0 kg/m2 (persisted for at least six months before screening)
  • Stable on their therapy (if any) for ≥ 3 months
  • Free of acute disorders and severe chronic diseases
  • Informed consent signed
  • Normal fasting breath hydrogen levels < 15 ppm

Exclusion Criteria:

  • History of dietary supplement use 4 weeks before the study commences
  • Abnormal values for lab clinical chemistry not related with stiyd outcomes (> 2 SD)
  • No consent to randomization
  • Unwillingness to return for follow-up analysis
  • Participation in other clinical trials
  • Participants starting or changing major treatments during the study period

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydrogen-rich water
1.0 L of hydrogen-rich water per day
Dietary supplement: Hydrogen-rich water
Hydrogen-rich water (1.0 L per day)
Active Comparator: Control
1.0 L of hydrogen-free water per day
Dietary supplement: Control
Hydrogen-free water (1.0 L per day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apolipoprotein B
Time Frame: Change from baseline apolipoprotein B at 6 months
Serum level of apolipoprotein B
Change from baseline apolipoprotein B at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipoprotein (a)
Time Frame: Change from baseline lipoprotein (a) at 6 months
Serum level of lipoprotein (a)
Change from baseline lipoprotein (a) at 6 months
GLP-1
Time Frame: Change from baseline GLP-1 at 6 months
Serum level of GLP-1
Change from baseline GLP-1 at 6 months
Short-chain fatty acids
Time Frame: Change from baseline short-chain fatty acids at 6 months
Serum level of short-chain fatty acids
Change from baseline short-chain fatty acids at 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat mass
Time Frame: Change from baseline body fat percentage at 6 months
Body fat percentage
Change from baseline body fat percentage at 6 months
Fasting breath hydrogen
Time Frame: Change from baseline breath levels of molecular hydrogen at fasting at 6 months
Breath levels of molecular hydrogen at fasting
Change from baseline breath levels of molecular hydrogen at fasting at 6 months
Post-prandial breath hydrogen
Time Frame: Change from baseline breath levels of molecular hydrogen after meal at 6 months
Breath levels of molecular hydrogen after meal
Change from baseline breath levels of molecular hydrogen after meal at 6 months

Collaborators and Investigators

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

Sponsor

Center for Health Sciences, Serbia

Investigators

  • Principal Investigator: Nikola Todorovic, PhD, Center for Mitochondrial Medicine

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 (Estimated)

April 15, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

February 15, 2027

Study Registration Dates

First Submitted

February 7, 2026

First Submitted That Met QC Criteria

February 7, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 7, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13012-20-01

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/overweight. 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/overweight.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • 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.

Clinical Trials on Overweight

Clinical Trials on Hydrogen-rich water

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe