NCT07098221

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 17, 2025

Last Update Submit

July 24, 2025

Conditions

Keywords

Hydrogen-rich waterResting metabolismEnergy expenditureSubstrate utilizationMetabolic rate

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

Study Arms (2)

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.

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

Dietary Supplement: Placebo Comparator

Interventions

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.

ARM1: 250 ml of Hydrogen Rich Water
Placebo ComparatorDIETARY_SUPPLEMENT

Non-hydrogen-producing tablets, identical in appearance and taste to the active supplement

ARM 2: 250 ml of Placebo Water (Non-hydrogen-producing tablets)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Hydrogen

Intervention Hierarchy (Ancestors)

ElementsInorganic ChemicalsGases

Central Study Contacts

Nikola Todorovic, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant, PhD

Study Record Dates

First Submitted

July 17, 2025

First Posted

August 1, 2025

Study Start

September 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share