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

NCT06961110 | Recruiting

• 1 other identifier: FTK_2024_110
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Body mass index

  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.

  Baseline and 4 weeks

• Six-minute walk test

  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.

  Baseline and 4 weeks

Secondary Outcomes (17)

• Body fat

  Baseline and 4 weeks

• 30-second sit-to-stand test

  Baseline and 4 weeks

• Maximal isometric grip force

  Baseline and 4 weeks

• Maximal wall sit

  Baseline and 4 weeks

• Resting blood lactate

  Baseline and 4 weeks

Other Outcomes (8)

• Waist circumference

  Baseline and 4 weeks

• Blood pressure

  Baseline and 4 weeks

• Hydration Status

  Baseline and 4 weeks

Study Arms (2)

Molecular hydrogen

EXPERIMENTAL

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).

Dietary Supplement: Hydrogen-rich water

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Hydrogen-rich water DIETARY_SUPPLEMENT

Hydrogen-rich water with molecular hydrogen concentration 1.2-1.6 ppm. No added sugar or preservatives.

Also known as: H2 Premium Hydrogen Water, H2 World Health & Beauty Company, Ostrava, Czech Republic

Molecular hydrogen

Placebo DIETARY_SUPPLEMENT

Drinking water with molecular hydrogen concentration 0.0 ppm. No added sugar or preservatives.

Also known as: H2 Premium Hydrogen Water (Placebo), H2 World Health & Beauty Company, Ostrava, Czech Republic

Placebo

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• High blood pressure.
• Dyslipoproteinemia.
• Cardio-respiratory disorders.
• Musculoskeletal disorders.
• Use of any medications regulating heart rhythm or the neurovegetative and hormonal system.

Sponsors & Collaborators

• Palacky University: lead

Study Sites (1)

Palacky University, Faculty of Physical Culture

Olomouc, Czech Republic, 77111, Czechia

RECRUITING

MeSH Terms

Conditions

Insulin Resistance; Inflammation

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Darja Supikova

  Palacky University, Faculty of Physical Culture

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darja Supikova

CONTACT

+420585636731; darja.supikova@upol.cz

Jakub Krejci, PhD

CONTACT

+420585636404; jakub.krejci@upol.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 1 year after the publication of results with no end date.

Locations

CZ (1)