Healthy Subjects or VolunteersH2RESTNCT07098221
Hydrogen-Rich Water and Resting Metabolism in Young Adults
A study testing Molecular Hydrogen in people with Healthy Subjects or Volunteers, run by University of Novi Sad.
Trial summary
The H2REST trial is a randomized, double-blind, placebo-controlled crossover study investigating the acute effects of a single dose of hydrogen-rich water (HRW) on resting metabolism in healthy young adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects or Volunteers
- What is being tested?
- Molecular Hydrogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Dec 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-35 years
- BMI between 18.5 and 25.0 kg/m²
- Apparently healthy, with no history of chronic disease
- Non-smoker, not currently using nicotine-containing products
- Able to provide informed consent
- Willing to refrain from alcohol, caffeine, and strenuous exercise for 24 hours before each study visit
- Able to comply with study procedures, including fasting and attending all study visits
Who cannot join
- Diagnosed metabolic, cardiovascular, respiratory, gastrointestinal, or endocrine disorders
- Use of dietary supplements or medications affecting metabolism (within the past 2 weeks)
- Allergy or intolerance to components of the hydrogen or placebo beverages
- Pregnant or lactating
- Shift work or irregular sleep schedule
- Participation in another clinical study within the past 30 days
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Hydrogen-Rich Water on Resting Metabolism in Healthy Young Adults: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial
The H2REST trial is a randomized, double-blind, placebo-controlled crossover study investigating the acute effects of a single dose of hydrogen-rich water (HRW) on resting metabolism in healthy young adults. Participants complete two testing sessions-receiving either HRW or placebo in a randomized order-followed by standardized metabolic testing. Primary outcomes include resting energy expenditure, respiratory exchange ratio, and substrate utilization measured via indirect calorimetry. The study aims to assess whether acute HRW intake can modulate metabolic rate and fuel preference at rest, and to explore inter-individual variability in response.
- Conditions
- Healthy Subjects or Volunteers
- Being tested
- Molecular Hydrogen, Placebo Comparator
- Keywords
- Hydrogen-rich water, Resting metabolism, Energy expenditure, Substrate utilization, Metabolic rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular HydrogenDietary supplement
Participants in this arm will consume a single 250 mL dose of hydrogen-rich water containing approximately 1.6-2.0 ppm of dissolved molecular hydrogen (H₂), The HRW will be ingested following an overnight fast, and resting metabolism will be measured approximately 30-60 minutes post-consumption using indirect calorimetry.
Placebo ComparatorDietary supplement
Non-hydrogen-producing tablets, identical in appearance and taste to the active supplement
| Study group | Role | What they receive |
|---|---|---|
| ARM1: 250 ml of Hydrogen Rich Water | Experimental | Hydrogen-producing tablets: Tablets designed to dissolve in water and release molecular hydrogen gas, creating hydrogen-rich water that can be consumed to potentially provide antioxidant and anti-inflammatory benefits. Receives: Dietary Supplement: Molecular Hydrogen |
| ARM 2: 250 ml of Placebo Water (Non-hydrogen-producing tablets) | Placebo comparator | Non-hydrogen-producing tablets, identical in appearance and taste to the active supplement Receives: Dietary Supplement: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Energy Expenditure (REE)
The measurements will be obtained during each study visit. Since this is an interventional study assessing the acute effects of molecular hydrogen, measurements will be collected three times:
At baseline, without any intervention (pre-familiarization),
After a single dose of molecular hydrogen, and
After placebo administration.
The period between each intervention will be seven days, serving as a washout period to prevent carry-over effects. All participants will be instructed to maintain their regular diet and to avoid alcohol, caffeine-containing beverages, and strenuous physical activity for at least 24 hours prior to each visit.
Measure Type: Continuous (kcal/day)
Method: Indirect calorimetry
Description: To assess the effect of acute ingestion of hydrogen-rich water versus placebo on resting energy expenditure in healthy young adults.
Measured: Participants will attend three study visits, with each intervention separated by a 7-day washout period to minimize carry-over effects. During each visit, measurements will be conducted approximately 30-60 minutes post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects or VolunteersStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikola Todorovic, University of Novi Sad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098221
- Sponsor's protocol ID
- 50-10-18/2024-3
- Acronym
- H2REST
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hydrogen-Rich Water on Resting Metabolism in Healthy Young Adults: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT07098221
- Acronym / sponsor ID
- H2REST / 50-10-18/2024-3
- Conditions
- Healthy Subjects or Volunteers
- Keywords
- Hydrogen-rich water, Resting metabolism, Energy expenditure, Substrate utilization, Metabolic rate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Novi SadUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 1 Aug 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.
The H2REST trial is a randomized, double-blind, placebo-controlled crossover study investigating the acute effects of a single dose of hydrogen-rich water (HRW) on resting metabolism in healthy young adults. Participants complete two testing sessions-receiving either HRW or placebo in a randomized order-followed by standardized metabolic testing. Primary outcomes include resting energy expenditure, respiratory exchange ratio, and substrate utilization measured via indirect calorimetry. The study aims to assess whether acute HRW intake can modulate metabolic rate and fuel preference at rest, and to explore inter-individual variability in response.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM1: 250 ml of Hydrogen Rich Water | Experimental | Dietary Supplement: Molecular HydrogenHydrogen-producing tablets: Tablets designed to dissolve in water and release molecular hydrogen gas, creating hydrogen-rich water that can be consumed to potentially provide antioxidant and anti-inflammatory benefits. |
| ARM 2: 250 ml of Placebo Water (Non-hydrogen-producing tablets) | Placebo comparator | Dietary Supplement: Placebo ComparatorNon-hydrogen-producing tablets, identical in appearance and taste to the active supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-35 years
- BMI between 18.5 and 25.0 kg/m²
- Apparently healthy, with no history of chronic disease
- Non-smoker, not currently using nicotine-containing products
- Able to provide informed consent
Key exclusion criteria (6 listed)
- Diagnosed metabolic, cardiovascular, respiratory, gastrointestinal, or endocrine disorders
- Use of dietary supplements or medications affecting metabolism (within the past 2 weeks)
- Allergy or intolerance to components of the hydrogen or placebo beverages
- Pregnant or lactating
- Shift work or irregular sleep schedule
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 |
|---|---|---|
| Molecular HydrogenParticipants in this arm will consume a single 250 mL dose of hydrogen-rich water containing approximately 1.6-2.0 ppm of dissolved molecular hydrogen (H₂), The HRW will be ingested following an overnight fast, and resting metabolism will be measured approximately 30-60 minutes post-consumption using indirect calorimetry. | Dietary supplement | ARM1: 250 ml of Hydrogen Rich Water |
| Placebo ComparatorNon-hydrogen-producing tablets, identical in appearance and taste to the active supplement | Dietary supplement | ARM 2: 250 ml of Placebo Water (Non-hydrogen-producing tablets) |
Primary outcome
Resting Energy Expenditure (REE)
Time frame: Participants will attend three study visits, with each intervention separated by a 7-day washout period to minimize carry-over effects. During each visit, measurements will be conducted approximately 30-60 minutes post-intervention.
The measurements will be obtained during each study visit. Since this is an interventional study assessing the acute effects of molecular hydrogen, measurements will be collected three times: At baseline, without any intervention (pre-familiarization), After a single dose of molecular hydrogen, and After placebo administration. The period between each intervention will be seven days, serving as a washout period to prevent carry-over effects. All participants will be instructed to maintain their regular diet and to avoid alcohol, caffeine-containing beverages, and strenuous physical activity for at least 24 hours prior to each visit. Measure Type: Continuous (kcal/day) Method: Indirect calorimetry Description: To assess the effect of acute ingestion of hydrogen-rich water versus placebo on resting energy expenditure in healthy young adults.
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 1 Aug 2025.
- Individual participant dataSharing planned: Yes
Related trials for Healthy Subjects or Volunteers
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Active, not recruitingPhase 1
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
Healthy Volunteers, Overweight or Obesity
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma
Healthy Volunteer Study, Healthy Adults
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.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular Hydrogen in people with Healthy Subjects or Volunteers, run by University of Novi Sad.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Nikola Todorovic, PhD (+381658417576, nikolatodorovic1708@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Energy Expenditure (REE) (time frame: Participants will attend three study visits, with each intervention separated by a 7-day washout period to minimize carry-over effects. During each visit, measurements will be conducted approximately 30-60 minutes post-intervention.). 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 1 Aug 2025.