Body CompositionNCT06961110
Evaluation of Molecular Hydrogen Supplementation to Enhance the Efficacy of Weight Loss Retreat in Overweight and Obese Adolescents
A study testing Hydrogen-rich water in people with Body Composition and Fitness, run by Palacky University at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Body Composition, Fitness, Insulin Sensitivity
- What is being tested?
- Hydrogen-rich water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 12 May 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- High blood pressure.
- Dyslipoproteinemia.
- Cardio-respiratory disorders.
- Musculoskeletal disorders.
- Use of any medications regulating heart rhythm or the neurovegetative and hormonal system.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Palacky University, Faculty of Physical Culture
Olomouc, Czech Republic, 77111
About this study
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
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.
Read the 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.
- Conditions
- Body Composition, Fitness, Insulin Sensitivity, Lipid Profile, Oxidative Stress, Inflammation
- Being tested
- Hydrogen-rich water, Placebo
- Medical subject headings
- Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen-rich waterDietary supplement
Also called H2 Premium Hydrogen Water, H2 World Health & Beauty Company, Ostrava, Czech Republic
Hydrogen-rich water with molecular hydrogen concentration 1.2-1.6 ppm. No added sugar or preservatives.
PlaceboDietary supplement
Also called H2 Premium Hydrogen Water (Placebo), H2 World Health & Beauty Company, Ostrava, Czech Republic
Drinking water with molecular hydrogen concentration 0.0 ppm. No added sugar or preservatives.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 4 weeks
Secondary outcomes (17)
Body fat
Body fat is measured using bioelectrical impedance analysis (InBody 270, InBody, Seoul, South Korea).
Measured: Baseline and 4 weeks
30-second sit-to-stand test
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.
Measured: Baseline and 4 weeks
Maximal isometric grip force
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.
Measured: Baseline and 4 weeks
Maximal wall sit
Maximal wall sit is measured by recording the maximum duration for which the participant can maintain a static isometric squat position against a wall.
Measured: Baseline and 4 weeks
Resting blood lactate
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.
Measured: Baseline and 4 weeks
Homeostatic model assessment of insulin resistance
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.
Measured: Baseline and 4 weeks
Total cholesterol
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.
Measured: Baseline and 4 weeks
Low-density lipoprotein
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.
Measured: Baseline and 4 weeks
High-density lipoprotein
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.
Measured: Baseline and 4 weeks
Triglycerides
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.
Measured: Baseline and 4 weeks
Cortisol
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.
Measured: Baseline and 4 weeks
Fibroblast growth factor 21
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.
Measured: Baseline and 4 weeks
Total antioxidant capacity
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.
Measured: Baseline and 4 weeks
Malondialdehydes
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.
Measured: Baseline and 4 weeks
Protein carbonyls
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.
Measured: Baseline and 4 weeks
Interleukin-6
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.
Measured: Baseline and 4 weeks
Tumor necrosis factor alpha
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.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start12 May 2025
- Primary completion29 May 2026
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Krejci, Palacky University
- Investigators
- Darja Supikova, Principal investigator, Palacky University, Faculty of Physical Culture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961110
- Sponsor's protocol ID
- FTK_2024_110
- Status last verified
- May 2026
- First submitted
- 29 Apr 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06961110
- Acronym / sponsor ID
- FTK_2024_110
- Conditions
- Body Composition, Fitness, Insulin Sensitivity, Lipid Profile, Oxidative Stress, Inflammation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Molecular hydrogen | Experimental | Dietary Supplement: Hydrogen-rich waterSupplementation 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). |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSupplementation with drinking water administered 1.5 L per day - before breakfast (500 ml), lunch (500 ml) and dinner (500 ml). |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- High blood pressure.
- Dyslipoproteinemia.
- Cardio-respiratory disorders.
- Musculoskeletal disorders.
- Use of any medications regulating heart rhythm or the neurovegetative and hormonal system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen-rich waterAlso: H2 Premium Hydrogen Water, H2 World Health & Beauty Company, Ostrava, Czech RepublicHydrogen-rich water with molecular hydrogen concentration 1.2-1.6 ppm. No added sugar or preservatives. | Dietary supplement | Molecular hydrogen |
| PlaceboAlso: H2 Premium Hydrogen Water (Placebo), H2 World Health & Beauty Company, Ostrava, Czech RepublicDrinking water with molecular hydrogen concentration 0.0 ppm. No added sugar or preservatives. | Dietary supplement | Placebo |
Primary outcome
Body mass index
Time frame: 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
Time frame: 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.
17 secondary outcomes
Body fat
Time frame: Baseline and 4 weeks
30-second sit-to-stand test
Time frame: Baseline and 4 weeks
Maximal isometric grip force
Time frame: Baseline and 4 weeks
Maximal wall sit
Time frame: Baseline and 4 weeks
Resting blood lactate
Time frame: Baseline and 4 weeks
Homeostatic model assessment of insulin resistance
Time frame: Baseline and 4 weeks
Total cholesterol
Time frame: Baseline and 4 weeks
Low-density lipoprotein
Time frame: Baseline and 4 weeks
High-density lipoprotein
Time frame: Baseline and 4 weeks
Triglycerides
Time frame: Baseline and 4 weeks
Cortisol
Time frame: Baseline and 4 weeks
Fibroblast growth factor 21
Time frame: Baseline and 4 weeks
Total antioxidant capacity
Time frame: Baseline and 4 weeks
Malondialdehydes
Time frame: Baseline and 4 weeks
Protein carbonyls
Time frame: Baseline and 4 weeks
Interleukin-6
Time frame: Baseline and 4 weeks
Tumor necrosis factor alpha
Time frame: Baseline and 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darja Supikova principal investigator
Palacky University, Faculty of Physical Culture
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen-rich water in people with Body Composition and Fitness, run by Palacky University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: Baseline and 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.