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

Evaluation of Molecular Hydrogen Supplementation to Enhance the Efficacy of Weight Loss Retreat in Overweight and Obese Adolescents. A Randomized, Double-blind, Parallel-group, Placebo-controlled Trial

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.

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.

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.