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

Not Applicable

Recruiting

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

• Registration Number: NCT06961110
• Lead Sponsor: Palacky University

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.

Study Timeline

• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Status Verified: 2025-05
• Study First Posted: 2025-05-07
• Study Start: 2025-05-12
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-11
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body mass index	Baseline and 4 weeks	Body mass index is calculated as the ratio of body mass (kg) to the square of body height (m2). Body mass is measured using a digital scale to the nearest 0.1 kg and body height is measured using a stadiometer to the nearest 1 cm.
Six-minute walk test	Baseline and 4 weeks	Six-minute walk test is measured by recording the total distance the participant is able to walk on a flat surface within six minutes. The participant is instructed to walk at his/her own pace in order to walk as far as possible in the given time.

Secondary Outcome Measures

Name	Time	Method
Interleukin-6	Baseline and 4 weeks	The level of interleukin-6 is measured from a fasting blood sample obtained via venipuncture by a healthcare specialist. The plasma is separated by centrifugation, divided into cryotubes, and stored at -80°C until ELISA analysis.
High-density lipoprotein	Baseline and 4 weeks	The level of high-density lipoprotein is measured from a fasting blood sample obtained via venipuncture by a healthcare specialist. The plasma is separated by centrifugation and analyzed using an enzymatic colorimetric method.
30-second sit-to-stand test	Baseline and 4 weeks	30-second sit-to-stand test is measured by counting the number of repetitions in which the participant rises from sitting in a chair and sits back down within 30 seconds.
Maximal isometric grip force	Baseline and 4 weeks	Maximal isometric grip force is measured using a hand dynamometer. The test is performed seated, with the elbow flexed at 90 degrees, and wrist in a neutral position.
Maximal wall sit	Baseline and 4 weeks	Maximal wall sit is measured by recording the maximum duration for which the participant can maintain a static isometric squat position against a wall.
Resting blood lactate	Baseline and 4 weeks	The level of resting blood lactate is measured using the Lactate Scout+ (EKF Diagnostics, Cardiff, United Kingdom). Capillary blood is collected in a fasting state from the fingertip using a sterile disposable lancet. Immediately after collection, the blood sample is applied to the test strip of the lactate meter and analyzed in real time.
Homeostatic model assessment of insulin resistance	Baseline and 4 weeks	Homeostatic model assessment of insulin resistance is calculated based on fasting glucose and fasting insulin levels measured from blood samples obtained via venipuncture by a healthcare specialist. Plasma glucose is separated by centrifugation and analyzed using an enzymatic colorimetric method. Serum insulin is separated by centrifugation and analyzed using a chemiluminescent immunoassay.
Total cholesterol	Baseline and 4 weeks	The level of total cholesterol is measured from a fasting blood sample obtained via venipuncture by a healthcare specialist. The plasma is separated by centrifugation and analyzed using an enzymatic colorimetric method.
Low-density lipoprotein	Baseline and 4 weeks	The level of low-density lipoprotein is measured from a fasting blood sample obtained via venipuncture by a healthcare specialist. The plasma is separated by centrifugation and analyzed using an enzymatic colorimetric method.
Triglycerides	Baseline and 4 weeks	The level of triglycerides is measured from a fasting blood sample obtained via venipuncture by a healthcare specialist. The plasma is separated by centrifugation and analyzed using an enzymatic colorimetric method.
Cortisol	Baseline and 4 weeks	The level of cortisol is measured from a fasting blood sample obtained via venipuncture by a healthcare specialist. The serum is separated by centrifugation and analyzed using a chemiluminescent immunoassay.
Fibroblast growth factor 21	Baseline and 4 weeks	The level of fibroblast growth factor 21 is measured from a fasting blood sample obtained via venipuncture by a healthcare specialist. The plasma is separated by centrifugation, divided into cryotubes, and stored at -80°C until ELISA analysis.
Total antioxidant capacity	Baseline and 4 weeks	The level of total antioxidant capacity is measured from a fasting blood sample obtained via venipuncture by a healthcare specialist. The plasma is separated by centrifugation, divided into cryotubes, and stored at -80°C until analysis using the TROLOX equivalent antioxidant capacity assay.
Malondialdehydes	Baseline and 4 weeks	The level of malondialdehydes is measured from a fasting blood sample obtained via venipuncture by a healthcare specialist. The plasma is separated by centrifugation, divided into cryotubes, and stored at -80°C until ELISA analysis.
Protein carbonyls	Baseline and 4 weeks	The level of protein carbonyls is measured from a fasting blood sample obtained via venipuncture by a healthcare specialist. The plasma is separated by centrifugation, divided into cryotubes, and stored at -80°C until ELISA analysis.
Tumor necrosis factor alpha	Baseline and 4 weeks	The level of tumor necrosis factor alpha is measured from a fasting blood sample obtained via venipuncture by a healthcare specialist. The plasma is separated by centrifugation, divided into cryotubes, and stored at -80°C until ELISA analysis.
Body fat	Baseline and 4 weeks	Body fat is measured using bioelectrical impedance analysis (InBody 270, InBody, Seoul, South Korea).

Trial Locations

Locations (1)

Palacky University, Faculty of Physical Culture; 🇨🇿 Olomouc, Czech Republic, Czechia