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Not yet recruiting NCT07410065

Supersaturated Hydrogen-Rich Water for Outpatients With Persistent Excess Weight

No phase Interventional Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydrogen-rich water, Control.
Who it may be relevant to
Registry conditions: Overweight. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Serbia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 supplement Hydrogen-rich water
    Hydrogen-rich water (1.0 L per day)
  • Dietary supplement Control
    Hydrogen-free water (1.0 L per day)

Primary outcome measures

  • Apolipoprotein B [Time frame: Change from baseline apolipoprotein B at 6 months]
Secondary outcome measures (3)
  • Lipoprotein (a) [Time frame: Change from baseline lipoprotein (a) at 6 months]
  • GLP-1 [Time frame: Change from baseline GLP-1 at 6 months]
  • Short-chain fatty acids [Time frame: Change from baseline short-chain fatty acids at 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Supportive care

Study locations

Serbia · 1 center
  • Center for Health Sciences — Belgrade

Publications

  • 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 40731927
  • 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 40251025
  • 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 37734117
  • 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 37560746
  • 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 37259294

Identifiers

NCT: NCT07410065 · 13012-20-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗