Evaluation of Molecular Hydrogen Supplementation to Enhance the Efficacy of Weight Loss Retreat in Overweight and Obese Adolescents

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2027-05-31

Brief Summary

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This randomized controlled trial evaluates whether molecular hydrogen supplementation enhances the effectiveness of a 4-week weight loss retreat in overweight and obese adolescents. Outcome measures include: body composition, physical status, blood samples (insulin sensitivity, lipid profiles, markers of oxidative stress and inflammation) and autonomic nervous system function.

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Detailed Description

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The aim of this randomized, double-blind, parallel-group, placebo-controlled trial is to evaluate whether molecular hydrogen supplementation enhances the effectiveness of weight loss retreat for overweight and obese adolescents. Weight loss retreat is indicated for participants based on diagnosis and recommendation of a pediatrician. During the 4-week retreat, participants follow a prescribed standardized intervention consisting of reduction diet and physical activity. The total planned number of participants is 60. Participants are randomly divided into two balanced groups, with one group receiving molecular hydrogen in the form of hydrogen-rich water and the other receiving a placebo water. The daily amount of water given (hydrogen-rich or placebo) is 1.5 L. Hydrogen-rich water is packaged in specially designed aluminum containers to minimize hydrogen leakage and ensure long-term stability with a dissolved hydrogen concentration of 1.2-1.6 ppm. Participants are unable to distinguish hydrogen-rich water from the placebo because molecular hydrogen is colorless, odorless, and tasteless. Participants monitor their physical activity, sleep, and sedentary behavior one week before to retreat and undergo baseline diagnostics (including blood sampling), three weekly interim diagnostics during retreat, and final diagnostics (including blood sampling) after four weeks. If participants are available, two follow-up diagnostics are conducted six weeks and six months after the retreat and include seven-day monitoring of physical activity, sleep, and sedentary behavior. Statistical analysis is performed at a significance level of α = 0.05 and the data is evaluated using analysis of variance. In cases of non-normality, data transformations or non-parametric alternatives are used.

Conditions

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Body Composition Fitness Insulin Sensitivity Lipid Profile Oxidative Stress Inflammation Autonomic Nervous System Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Molecular hydrogen

Supplementation with molecular hydrogen in the form of hydrogen-rich water administered 1.5 L per day - before breakfast (500 ml), lunch (500 ml) and dinner (500 ml).

Group Type EXPERIMENTAL

Hydrogen-rich water

Intervention Type DIETARY_SUPPLEMENT

Hydrogen-rich water with molecular hydrogen concentration 1.2-1.6 ppm. No added sugar or preservatives.

Placebo

Supplementation with drinking water administered 1.5 L per day - before breakfast (500 ml), lunch (500 ml) and dinner (500 ml).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Drinking water with molecular hydrogen concentration 0.0 ppm. No added sugar or preservatives.

Interventions

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Hydrogen-rich water

Hydrogen-rich water with molecular hydrogen concentration 1.2-1.6 ppm. No added sugar or preservatives.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Drinking water with molecular hydrogen concentration 0.0 ppm. No added sugar or preservatives.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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H2 Premium Hydrogen Water, H2 World Health & Beauty Company, Ostrava, Czech Republic H2 Premium Hydrogen Water (Placebo), H2 World Health & Beauty Company, Ostrava, Czech Republic

Eligibility Criteria

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Inclusion Criteria

* Body mass index indicating overweight or obesity, as determined according to the World Health Organization's international percentile charts for children aged 5-19 years.
* Presence of a regular menstrual cycle in female participants.
* Signed informed consent from the legal representative.

Exclusion Criteria

* High blood pressure.
* Dyslipoproteinemia.
* Cardio-respiratory disorders.
* Musculoskeletal disorders.
* Use of any medications regulating heart rhythm or the neurovegetative and hormonal system.

Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No