None listed
Conditions
Brief summary
This pilot study assesses the feasibility and preliminary efficacy of utilising hydrogen-rich water for adults with metabolic syndrome. Participants will be randomised to drink either hydrogen-rich water or a placebo daily for 12 weeks in a double-blind design. The primary objective is to evaluate trial feasibility by measuring participant retention and adherence to dosing. Secondary objectives include evaluating early changes in waist circumference, blood pressure, blood sugar, and cholesterol levels compared to the placebo group. It is hypothesized that the trial design will prove feasible and that preliminary data will show a trend toward reduced waist size, thereby supporting the design of a larger, fully powered future trial.
Interventions
Hydrogen-rich water, generated by dissolving a hydrogen-generating effervescent tablet (releasing ~4 mg H2) in ~250 mL of room-temperature water, consumed on an empty stomach.
Participants self-administer at home after instruction. Tablets are dispensed by GCP-trained research staff at in-person visits, under the oversight of the Chief Investigator and co-investigators.
This is a self-administered oral supplement, not a behavioural or group intervention.
Three tablets/day (~12 mg H2/day total fo
Hydrogen-rich water, generated by dissolving a hydrogen-generating effervescent tablet (releasing ~4 mg H2) in ~250 mL of room-temperature water, consumed on an empty stomach. Participants self-administer at home after instruction. Tablets are dispensed by GCP-trained research staff at in-person visits, under the oversight of the Chief Investigator and co-investigators. This is a self-administered oral supplement, not a behavioural or group intervention. Three tablets/day (~12 mg H2/day total for the active arm), dissolved and consumed three times daily (morning, midday, evening), for 12 consecutive weeks. Daily consumption occurs at the participant's home. Dispensing and study assessments occur at the Exercise Physiology Clinic Laboratory, Building B, Room B9.33, Southern Cross University Gold Coast Campus. Adherence: Returned/unused tablet counts at each visit, logged in an IP accountability log, compared against an adherence target of at least 80%.
Sponsors
Southern Cross University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Adults aged 18–65 years Diagnosed with metabolic syndrome, meeting at least 3 of the following: Waist circumference at least 102 cm (men) or at least 88 cm (women) (greater than or equal to) Fasting triglycerides greater than 1.7 mmol/L, or currently receiving treatment for elevated triglycerides Fasting high-density lipoprotein cholesterol (HDL-C) less than 1.0 mmol/L (men) or less than 1.3 mmol/L (women), or currently receiving treatment for low HDL-C Fasting glucose at least 5.6 mmol/L, or currently receiving treatment for elevated glucose Blood pressure at least 130/85 mmHg, or currently receiving antihypertensive treatment (greater than or equal to)
Exclusion criteria
Pregnancy or breastfeeding Current smoking Excessive alcohol consumption, defined as an average intake of more than 10 standard drinks per week, or more than 4 standard drinks on a single occasion on a regular basis Use of hormonal contraceptives or antioxidant supplements Use of antibiotics, probiotics, or microbiota regulators within the past 2 months Active or clinically significant gastrointestinal, autoimmune, or chronic inflammatory conditions (e.g. inflammatory bowel disease, coeliac disease, rheumatoid arthritis, lupus) History of myocardial infarction, stroke, cancer, liver or kidney disorders, or severe mental health disorders Positive for HIV infection or chronic dysentery
Outcome results
None listed