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

Not Applicable

Recruiting

• Conditions: Metabolic Syndrome

• Registration Number: NCT06968715
• Lead Sponsor: University of Novi Sad, Faculty of Sport and Physical Education

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-05
• Last Update Submitted: 2025-05-05
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-10-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Waist circumference	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 Outcome Measures

Name	Time	Method
Body fat	Change from baseline body fat at 12 weeks	Body fat measured with bioimpedance analysis
Lipoprotein (a)	Change from baseline lipoprotein (a) at 12 weeks	Serum levels of lipoprotein (a)
Total antioxidant capacity	Change from baseline total antioxidant capacity at 12 weeks	Serum levels of total antioxidant capacity

Trial Locations

Locations (1)

Applied Bioenergetics Lab at Faculty of Sport and PE; 🇷🇸 Novi Sad, Vojvodina, Serbia