NCT07410065

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress20%
Apr 2026Feb 2027

First Submitted

Initial submission to the registry

February 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 7, 2026

Last Update Submit

February 7, 2026

Conditions

Overweight

Keywords

MetabolismHydrogen

Outcome Measures

Primary Outcomes (1)

  • Apolipoprotein B

    Serum level of apolipoprotein B

    Change from baseline apolipoprotein B at 6 months

Secondary Outcomes (3)

  • Lipoprotein (a)

    Change from baseline lipoprotein (a) at 6 months

  • GLP-1

    Change from baseline GLP-1 at 6 months

  • Short-chain fatty acids

    Change from baseline short-chain fatty acids at 6 months

Other Outcomes (3)

  • Fat mass

    Change from baseline body fat percentage at 6 months

  • Fasting breath hydrogen

    Change from baseline breath levels of molecular hydrogen at fasting at 6 months

  • Post-prandial breath hydrogen

    Change from baseline breath levels of molecular hydrogen after meal at 6 months

Study Arms (2)

Hydrogen-rich water

EXPERIMENTAL

1.0 L of hydrogen-rich water per day

Dietary Supplement: Hydrogen-rich water

Control

ACTIVE COMPARATOR

1.0 L of hydrogen-free water per day

Dietary Supplement: Control

Interventions

Hydrogen-rich waterDIETARY_SUPPLEMENT

Hydrogen-rich water (1.0 L per day)

Hydrogen-rich water
ControlDIETARY_SUPPLEMENT

Hydrogen-free water (1.0 L per day)

Control

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health Sciences

Belgrade, 11000, Serbia

Location

Related Publications (5)

  • 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: 40731927BACKGROUND

  • Todorovic N, Kuzmanovic J, Javorac D, Ostojic SM. Role of molecular hydrogen in obesity treatment: modulation of GLP-1, irisin, and PGC-1alpha for improved metabolism. Med Gas Res. 2025 Sep 1;15(3):442-443. doi: 10.4103/mgr.MEDGASRES-D-24-00146. Epub 2025 Feb 7. No abstract available.

    PMID: 40251025BACKGROUND

  • Korovljev D, Todorovic N, Ranisavljev M, Andjelic B, Kladar N, Stajer V, Ostojic SM. Hydrogen-rich water upregulates fecal propionic acid levels in overweight adults. Nutrition. 2023 Dec;116:112200. doi: 10.1016/j.nut.2023.112200. Epub 2023 Sep 1. No abstract available.

    PMID: 37734117BACKGROUND

  • 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, Fernandez-Landa J, Santibanez A, Kura B, Stajer V, Korovljev D, Ostojic SM. The Effects of Hydrogen-Rich Water on Blood Lipid Profiles in Clinical Populations: A Systematic Review and Meta-Analysis. Pharmaceuticals (Basel). 2023 Jan 18;16(2):142. doi: 10.3390/ph16020142.

    PMID: 37259294BACKGROUND

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nikola Todorovic, PhD

    Center for Mitochondrial Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergej Ostojic, MD, PhD

CONTACT

+381112643242sergej.ostojic@chess.edu.rs

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 13, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

February 15, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
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/overweight.

Locations

SE(1)