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

Last updated: May 12, 2025
Sponsor: Palacky University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Body Composition

Inflammation

Weight Loss

Treatment

Hydrogen-rich water

Placebo

Clinical Study ID

NCT06961110
FTK_2024_110
  • Ages 11-18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index indicating overweight or obesity, as determined according to theWorld Health Organization's international percentile charts for children aged 5-19years.

  • Presence of a regular menstrual cycle in female participants.

  • Signed informed consent from the legal representative.

Exclusion

Exclusion Criteria:

  • High blood pressure.

  • Dyslipoproteinemia.

  • Cardio-respiratory disorders.

  • Musculoskeletal disorders.

  • Use of any medications regulating heart rhythm or the neurovegetative and hormonalsystem.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Hydrogen-rich water
Phase:
Study Start date:
May 12, 2025
Estimated Completion Date:
May 31, 2027

Study Description

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.

Connect with a study center

  • Palacky University, Faculty of Physical Culture

    Olomouc, 77111
    Czech Republic

    Site Not Available

  • Palacky University, Faculty of Physical Culture

    Olomouc, Czech Republic 77111
    Czechia

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.