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

NCT ID: NCT06968715

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-11-30

Brief Summary

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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

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental 1: low-breath hydrogen

One liter of hydrogen-rich water per day

Group Type EXPERIMENTAL

Experimental 1: low-breath hydrogen

Intervention Type DIETARY_SUPPLEMENT

Hydrogen-rich water (1.0 L/day)

Experimental 2: high-breath hydrogen

One liter of hydrogen-rich water per day

Group Type EXPERIMENTAL

Experimental 2: high-breath hydrogen

Intervention Type DIETARY_SUPPLEMENT

Hydrogen-rich water (1.0 L/day)

Experimental 3: low-breath hydrogen

One liter of control water per day

Group Type PLACEBO_COMPARATOR

Experimental 3: low-breath hydrogen

Intervention Type DIETARY_SUPPLEMENT

Placebo water (1.0 L/day)

Experimental 4: high-breath hydrogen

One liter of control water per day

Group Type PLACEBO_COMPARATOR

Experimental 4: high-breath hydrogen

Intervention Type DIETARY_SUPPLEMENT

Placebo water (1.0 L/day)

Interventions

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Experimental 1: low-breath hydrogen

Hydrogen-rich water (1.0 L/day)

Intervention Type DIETARY_SUPPLEMENT

Experimental 2: high-breath hydrogen

Hydrogen-rich water (1.0 L/day)

Intervention Type DIETARY_SUPPLEMENT

Experimental 3: low-breath hydrogen

Placebo water (1.0 L/day)

Intervention Type DIETARY_SUPPLEMENT

Experimental 4: high-breath hydrogen

Placebo water (1.0 L/day)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Novi Sad, Faculty of Sport and Physical Education

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, Serbia

Site Status

Countries

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Serbia

Other Identifiers

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51-02-01

Identifier Type: -

Identifier Source: org_study_id