Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001047381p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
12/11/2025
Date registered
Help: Date registered
26/08/2026
Date last updated
Help: Date last updated
26/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
26/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Hydrogen-Rich Water Supplementation for Adults with Excess Weight
Scientific title
Hydrogen-Rich Water Supplementation in Adults with Excess Weight: A Randomised, Double-Blind, Placebo-Controlled Translational Study
Additional trial identifiers [1] 315909 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Excess Weight 339696 0
Obesity 342454 0
Metabolic Syndrome 342457 0
Condition category
Condition code
Metabolic and Endocrine 335941 335941 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Description:

Participants allocated to the intervention group will consume hydrogen-rich water (HRW) daily for 6 months. The intervention will provide approximately 16 mg of molecular hydrogen (H2) per day, administered as approximately 1.0 L of HRW divided into three daily servings (approximately 333 mL per serving). Participants will be instructed to consume one serving in the morning, one in the early afternoon, and one before dinner.

The hydrogen-rich water will be prepared using commercially available hydrogen-generating tablets supplied by the Industry Partner and legally supplied in Australia. Participants will receive detailed written instructions regarding preparation and consumption of the intervention. All intervention materials will be provided by the research team.

Delivery and provider: Self-administered oral consumption by participants, with oversight from the study investigators and research staff.

Duration and location: 6 months. Participants will consume the intervention at home and attend study visits at baseline and 6 months for clinical assessments and biological sample collection.

Compliance monitoring: Compliance will be assessed through participant logs, tablet counts, and regular contact with the research team. Adverse events and any changes to medications or health status will be recorded throughout the study period.

Additional notes: Participants will be instructed to maintain their usual diet, physical activity patterns, and prescribed medications throughout the study unless otherwise advised by their healthcare provider.
Intervention code [1] 332515 0
Lifestyle
Intervention code [2] 332615 0
Treatment: Other
Description of the comparator or control
Comparator name: Placebo tablets (CO2-generating instead of H2)

Description:

Participants allocated to the control group will consume placebo water daily for 6 months. The placebo treatment will consist of placebo tablets matched to the active tablets in appearance, taste, smell, and effervescence, but generating carbon dioxide (CO2) rather than molecular hydrogen (H2). Participants will consume approximately 1.0 L of placebo water per day, divided into three daily servings (approximately 333 mL per serving), with one serving consumed in the morning, one in the early afternoon, and one before dinner.

The placebo treatment will be self-administered orally by participants at home. Participants will place one placebo tablet into approximately 333 mL of room-temperature water, allow it to dissolve completely for 1–2 minutes, and then consume the solution immediately. Each dose will be taken on an empty stomach, with doses spaced approximately 4–6 hours apart throughout the day.

The preparation instructions, dosing schedule, monitoring procedures, and compliance requirements will be identical to those used in the intervention group. Adherence will be monitored through regular participant contact, tablet counts returned at study visits, and recording of any adverse events throughout the study period.
Control group
Placebo

Outcomes
Primary outcome [1] 343455 0
Change in body weight and body composition, assessed by body weight, BMI, waist circumference, and DEXA-derived fat mass.
Timepoint [1] 343455 0
Baseline and 6 months post-intervention.
Primary outcome [2] 343456 0
Change in cardiometabolic risk, assessed by apolipoprotein B (ApoB) and lipid profile.
Timepoint [2] 343456 0
Baseline and 6 months post-intervention.
Primary outcome [3] 343620 0
Change in glycaemic control from baseline to 6 months, assessed by fasting glucose, HbA1c, and glucose tolerance test.
Timepoint [3] 343620 0
Baseline and 6 months post-intervention.
Secondary outcome [1] 454470 0
Change in oxidative stress markers from baseline to 6 months, assessed by TBARS and 8-OHdG.
Timepoint [1] 454470 0
Baseline and 6 months post-intervention.
Secondary outcome [2] 454471 0
Change in inflammatory markers from baseline to 6 months, assessed by hs-CRP, IL-6, and TNF-a.
Timepoint [2] 454471 0
Baseline and 6 months post-intervention.
Secondary outcome [3] 454472 0
Change in gut microbiota composition from baseline to 6 months, assessed by 16S rRNA sequencing and Akkermansia muciniphila abundance.
Timepoint [3] 454472 0
Baseline and 6 months post-intervention.
Secondary outcome [4] 454900 0
Change in breath hydrogen and related metabolic markers from baseline to 6 months, assessed under fasting and post-prandial conditions.
Timepoint [4] 454900 0
Baseline and 6 months post-intervention.

Eligibility
Key inclusion criteria
Adults aged 20–50 years.
Body mass index (BMI) greater than 25.0 kg m2
Normal fasting breath hydrogen levels, i.e., up to 15 ppm
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Current smokers.
Pregnant women.
Use of dietary supplements within four weeks before study commencement.
Abnormal clinical laboratory values unrelated to the study outcomes.
Acute inflammatory or infectious diseases.
Unwillingness to attend follow-up assessments or comply with study procedures.
Participation in another clinical trial.
Planned initiation or modification of major treatments during the study period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed via a computer-based central randomisation system managed by a researcher not involved in participant recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to intervention or placebo groups using a computer-generated randomisation sequence. A block randomisation method will be used to ensure balanced group sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using appropriate parametric or non-parametric tests following assessment of normality. Changes over time and between groups will be assessed using two-way repeated-measures ANOVA (group × time), with post hoc analyses performed where appropriate. Statistical significance will be set at p < 0.05. All analyses will be conducted using SPSS or equivalent statistical software.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
1/02/2027
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 320511 0
Commercial sector/Industry
Name [1] 320511 0
Natural Wellness Now Health Products Inc
Country [1] 320511 0
Canada
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 323134 0
Commercial sector/Industry
Name [1] 323134 0
Natural Wellness Now Health Products Inc
Address [1] 323134 0
Country [1] 323134 0
Canada

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 319054 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 319054 0
Ethics committee country [1] 319054 0
Australia
Date submitted for ethics approval [1] 319054 0
17/07/2026
Approval date [1] 319054 0
Ethics approval number [1] 319054 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 146114 0
Dr Vinicius Cruzat
Address 146114 0
La Trobe University, Plenty Road, Bundoora, Victoria 3086
Country 146114 0
Australia
Phone 146114 0
+61 0490795199
Fax 146114 0
Email 146114 0
[email protected]
Contact person for public queries
Name 146115 0
Vinicius Cruzat
Address 146115 0
La Trobe University, Plenty Road, Bundoora, Victoria 3086
Country 146115 0
Australia
Phone 146115 0
+61 0490795199
Fax 146115 0
Email 146115 0
[email protected]
Contact person for scientific queries
Name 146116 0
Vinicius Cruzat
Address 146116 0
La Trobe University, Plenty Road, Bundoora, Victoria 3086
Country 146116 0
Australia
Phone 146116 0
+61 0490795199
Fax 146116 0
Email 146116 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.