- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07098221
- Original Trial
Hydrogen-Rich Water and Resting Metabolism in Young Adults (H2REST)
Effects of Hydrogen-Rich Water on Resting Metabolism in Healthy Young Adults: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nikola Todorovic, PhD
- Phone Number: +381658417576
- Email: nikolatodorovic1708@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ARM1: 250 ml of Hydrogen Rich Water
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.
|
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 Comparator: ARM 2: 250 ml of Placebo Water (Non-hydrogen-producing tablets)
Non-hydrogen-producing tablets, identical in appearance and taste to the active supplement
|
Non-hydrogen-producing tablets, identical in appearance and taste to the active supplement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 50-10-18/2024-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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