Supersaturated Hydrogen-Rich Water for Outpatients With Persistent Excess Weight

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07410065

Acronym

HOPE

Enrollment

120

Registered

2026-02-13

Start date

2026-04-15

Completion date

2027-02-15

Last updated

2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

Keywords

Metabolism, Hydrogen

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.

Interventions

DIETARY_SUPPLEMENTHydrogen-rich water

Hydrogen-rich water (1.0 L per day)

DIETARY_SUPPLEMENTControl

Hydrogen-free water (1.0 L per day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Apolipoprotein B	Change from baseline apolipoprotein B at 6 months	Serum level of apolipoprotein B

Secondary

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

Countries

Serbia

Contacts

CONTACTSergej Ostojic, MD, PhD

sergej.ostojic@chess.edu.rs+381112643242

PRINCIPAL_INVESTIGATORNikola Todorovic, PhD

Center for Mitochondrial Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026