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

Palacky University

Status: Not yet enrolling

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

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Hydrogen-rich water

Study type: Interventional

Funder types: Other

Identifiers

NCT06961110

FTK_2024_110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Molecular hydrogen

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Hydrogen-rich water

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo