Clinical trial NCT06961110: Evaluation of Molecular Hydrogen Supplementation to Enhance the Efficacy of Weight Loss Retreat in Overweight and Obese Adolescents
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Body Composition
Fitness
Insulin Sensitivity
Lipid Profile
Oxidative Stress
Inflammation
Autonomic Nervous System Activity
Lead sponsor: Palacky University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body mass index
timeFrame: Baseline and 4 weeks
measure: Six-minute walk test
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Body fat
timeFrame: Baseline and 4 weeks
measure: 30-second sit-to-stand test
timeFrame: Baseline and 4 weeks
measure: Maximal isometric grip force
timeFrame: Baseline and 4 weeks
measure: Maximal wall sit
timeFrame: Baseline and 4 weeks
measure: Resting blood lactate
timeFrame: Baseline and 4 weeks
measure: Homeostatic model assessment of insulin resistance
timeFrame: Baseline and 4 weeks
measure: Total cholesterol
timeFrame: Baseline and 4 weeks
measure: Low-density lipoprotein
timeFrame: Baseline and 4 weeks
measure: High-density lipoprotein
timeFrame: Baseline and 4 weeks
measure: Triglycerides
timeFrame: Baseline and 4 weeks
measure: Cortisol
timeFrame: Baseline and 4 weeks
measure: Fibroblast growth factor 21
timeFrame: Baseline and 4 weeks
measure: Total antioxidant capacity
timeFrame: Baseline and 4 weeks
measure: Malondialdehydes
timeFrame: Baseline and 4 weeks
measure: Protein carbonyls
timeFrame: Baseline and 4 weeks
measure: Interleukin-6
timeFrame: Baseline and 4 weeks
measure: Tumor necrosis factor alpha
timeFrame: Baseline and 4 weeks
Other outcomes:
measure: Waist circumference
timeFrame: Baseline and 4 weeks
measure: Blood pressure
timeFrame: Baseline and 4 weeks
measure: Hydration Status
timeFrame: Baseline and 4 weeks
measure: Subjective evaluation of lower limb soreness
timeFrame: Baseline and 4 weeks
measure: Heart rate variability
timeFrame: Baseline and 4 weeks
measure: Physical Activity Level
timeFrame: Baseline and 4 weeks
measure: Sedentary Behavior
timeFrame: Baseline and 4 weeks
measure: Sleep duration
timeFrame: Baseline and 4 weeks
Locations:
city: Olomouc
country: Czechia
facility: Palacky University, Faculty of Physical Culture
state: Czech Republic
Study officials:
affiliation: Palacky University, Faculty of Physical Culture
name: Darja Supikova
role: PRINCIPAL_INVESTIGATOR
References: