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NCT Number: NCT07410065

Supersaturated Hydrogen-Rich Water for Outpatients With Persistent Excess Weight

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Health Sciences

Belgrade, 11000, Serbia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrogen-rich water

Dietary Supplement

Hydrogen-rich water (1.0 L per day)

Control

Dietary Supplement

Hydrogen-free water (1.0 L per day)

Primary outcomes

  1. Apolipoprotein B

    Time frame: Change from baseline apolipoprotein B at 6 months

    Serum level of apolipoprotein B

Secondary outcomes

  1. Lipoprotein (a)

    Time frame: Change from baseline lipoprotein (a) at 6 months

    Serum level of lipoprotein (a)

  2. GLP-1

    Time frame: Change from baseline GLP-1 at 6 months

    Serum level of GLP-1

  3. Short-chain fatty acids

    Time frame: Change from baseline short-chain fatty acids at 6 months

    Serum level of short-chain fatty acids

Other outcomes

  1. Fat mass

    Time frame: Change from baseline body fat percentage at 6 months

    Body fat percentage

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sergej Ostojic, MD, PhD

CONTACT

[email protected]

+381112643242

Sponsors and collaborators

Lead sponsor

Center for Health Sciences, Serbia

Other

Registry information

Official study title

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

Acronym: HOPE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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