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

NCT06968715 | Completed

• 1 other identifier: 51-02-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Waist circumference

  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.

  Change from baseline waist circumference at 12 weeks

Secondary Outcomes (3)

• Body fat

  Change from baseline body fat at 12 weeks

• Lipoprotein (a)

  Change from baseline lipoprotein (a) at 12 weeks

• Total antioxidant capacity

  Change from baseline total antioxidant capacity at 12 weeks

Study Arms (4)

Experimental 1: low-breath hydrogen

EXPERIMENTAL

One liter of hydrogen-rich water per day

Dietary Supplement: Experimental 1: low-breath hydrogen

Experimental 2: high-breath hydrogen

EXPERIMENTAL

One liter of hydrogen-rich water per day

Dietary Supplement: Experimental 2: high-breath hydrogen

Experimental 3: low-breath hydrogen

PLACEBO COMPARATOR

One liter of control water per day

Dietary Supplement: Experimental 3: low-breath hydrogen

Experimental 4: high-breath hydrogen

PLACEBO COMPARATOR

One liter of control water per day

Dietary Supplement: Experimental 4: high-breath hydrogen

Interventions

Experimental 1: low-breath hydrogen DIETARY_SUPPLEMENT

Hydrogen-rich water (1.0 L/day)

Experimental 1: low-breath hydrogen

Experimental 2: high-breath hydrogen DIETARY_SUPPLEMENT

Hydrogen-rich water (1.0 L/day)

Experimental 2: high-breath hydrogen

Experimental 3: low-breath hydrogen DIETARY_SUPPLEMENT

Placebo water (1.0 L/day)

Experimental 3: low-breath hydrogen

Experimental 4: high-breath hydrogen DIETARY_SUPPLEMENT

Placebo water (1.0 L/day)

Experimental 4: high-breath hydrogen

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Novi Sad, Faculty of Sport and Physical Education: lead

Study Sites (1)

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: April 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Only qualified researchers with academic interest in metabolic syndrome or molecular hydrogen research

Locations

SE (1)