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NCT Number: NCT06968715

Hydrogen-Rich Water and Metabolic Health in Adults: A 12-Week Randomized Trial

The HYDRO-RESPOND trial is a 12-week randomized controlled study investigating the effects of daily hydrogen-rich water (HRW) consumption on body composition and metabolic biomarkers in adults diagnosed with metabolic syndrome. The study also explores whether individual differences in baseline breath hydrogen levels influence response to HRW. Participants are randomly assigned to receive either HRW or a placebo, with outcomes including changes in body fat, waist circumference, glucose metabolism, lipid profiles, and inflammatory markers. The trial aims to determine the therapeutic potential of HRW and identify predictors of individual responsiveness.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 30-65 years
  • Metabolic syndrome (NHS) (at least 3 of the 5 following criteria):
  • Waist circumference of ≥ 102 cm in men and ≥ 88 cm in women
  • Hypertriglyceridemia (≥ 1.695 mmol/L)
  • Low HDL-C (< 1.04 mmol/dL in men and < 1.30 mmol/dL in women)
  • High blood pressure (> 130/85 mmHg)
  • High fasting glucose (> 6.1 mmol/L)
  • Not physically active
  • Informed consent signed

Exclusion criteria

  • Major chronic disease and acute injuries
  • History of dietary supplement use during the past 4 weeks
  • History of metabolism-modulating pharmaceuticals use during the past 4 weeks
  • No consent to randomization
  • Participation in other studies

Treatment and study plan

Experimental 1: low-breath hydrogen

Dietary Supplement

Hydrogen-rich water (1.0 L/day)

Experimental 2: high-breath hydrogen

Dietary Supplement

Hydrogen-rich water (1.0 L/day)

Experimental 3: low-breath hydrogen

Dietary Supplement

Placebo water (1.0 L/day)

Experimental 4: high-breath hydrogen

Dietary Supplement

Placebo water (1.0 L/day)

Primary outcomes

  1. Waist circumference

    Time frame: Change from baseline waist circumference at 12 weeks

    Waist circumference, measured at the midpoint between the lower rib and iliac crest, serves as an indicator of abdominal adiposity and a key outcome reflecting metabolic risk.

Secondary outcomes

  1. Body fat

    Time frame: Change from baseline body fat at 12 weeks

    Body fat measured with bioimpedance analysis

  2. Lipoprotein (a)

    Time frame: Change from baseline lipoprotein (a) at 12 weeks

    Serum levels of lipoprotein (a)

  3. Total antioxidant capacity

    Time frame: Change from baseline total antioxidant capacity at 12 weeks

    Serum levels of total antioxidant capacity

Sponsors and collaborators

Lead sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Other

Registry information

Official study title

The Effects of 12-week Hydrogen-rich Water Consumption on Body Composition and Metabolic Biomarkers in Adults With Metabolic Syndrome and Varying Breath Hydrogen Levels

Acronym: HYDRO-RESPOND

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 13, 2025
Registry last updated
Dec 22, 2025

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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