Authors
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La Trobe University -More
Category
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Primary study
Registry of Trials»Australian New Zealand Clinical Trials Registry
Year
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2026
INTERVENTION: 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. CONDITION: Excess Weight;Obesity;Metabolic Syndrome; ; Excess Weight ; Obesity ; Metabolic Syndrome Metabolic and Endocrine ‐ Metabolic disorders PRIMARY OUTCOME: Change in body weight and body composition, assessed by body weight, BMI, waist circumference, and DEXA‐derived fat mass.[Calibrated scale and stadiometer for body weight/BMI, non‐stretch tape measure for waist, abdominal and hip circumferences, and dual‐energy X‐ray absorptiometry (DEXA) for fat mass and fat‐free mass. Baseline and 6 months post‐intervention.] Change in cardiometabolic risk, assessed by apolipoprotein B (ApoB) and lipid profile.[Fasting venous blood sample analysed by the institutional clinical pathology laboratory for apolipoprotein B (ApoB), lipoprotein(a), and lipid profile using standard biochemical/immunoassay methods. Baseline and 6 months post‐intervention.] Change in glycaemic control from baseline to 6 months, assessed by fasting glucose, HbA1c, and glucose tolerance test.[Fasting venous blood sample analysed by the institutional clinical pathology laboratory for fasting glucose, glycated haemoglobin (HbA1c), insulin, and glucose tolerance test (GTT) measurements using standard clinical assays. Baseline and 6 months post‐intervention.] INCLUSION CRITERIA: Adults aged 20–50 years. Body mass inde X(BMI) greater than 25.0 kg m2 Normal fasting breath hydrogen levels, i.e., up to 15 ppm SECONDARY OUTCOME: Change in breath hydrogen and related metabolic markers from baseline to 6 months, assessed under fasting and post‐prandial conditions.[Breath hydrogen will be measured under fasting and post‐prandial conditions using standard breath hydrogen testing. Baseline and 6 months post‐intervention.] Change in gut microbiota composition from baseline to 6 months, assessed by 16S rRNA sequencing and Akkermansia muciniphila abundance. ; [Stool samples analysed by 16S rRNA sequencing, including assessment of Akkermansia muciniphila abundance. Baseline and 6 months post‐intervention.] Change in inflammatory markers from baseline to 6 months, assessed by hs‐CRP, IL‐6, and TNF‐a.[Fasting venous blood sample analysed for high‐sensitivity C‐reactive protein (hs‐CRP), and inflammatory cytokines such as IL‐6 and TNF‐a, together with complete blood count and differential using standard pathology methods. Baseline and 6 months post‐intervention.] Change in oxidative stress markers from baseline to 6 months, assessed by TBARS and 8‐OHdG. ; [Fasting venous blood sample analysed for thiobarbituric acid reactive substances (TBARS) and 8‐hydroxy‐2'‐deoxyguanosine (8‐OHdG) using standard laboratory assays. Baseline and 6 months post‐intervention.]
Epistemonikos ID: a6a62287386422f964dad0fb6b237f91e2ceff6f
First added on: Oct 08, 2026