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The HYDRO-RESPOND trial is a 12-week randomized controlled study investigating the effects of daily hydrogen-rich water (HRW) consumption on body composition and metabolic biomarkers in adults diagnosed with metabolic syndrome. The study also explores whether individual differences in baseline breath hydrogen levels influence response to HRW. Participants are randomly assigned to receive either HRW or a placebo, with outcomes including changes in body fat, waist circumference, glucose metabolism, lipid profiles, and inflammatory markers. The trial aims to determine the therapeutic potential of HRW and identify predictors of individual responsiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1: low-breath hydrogen | Experimental | One liter of hydrogen-rich water per day |
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| Experimental 2: high-breath hydrogen | Experimental | One liter of hydrogen-rich water per day |
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| Experimental 3: low-breath hydrogen | Placebo Comparator | One liter of control water per day |
|
| Experimental 4: high-breath hydrogen | Placebo Comparator | One liter of control water per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental 1: low-breath hydrogen | Dietary Supplement | Hydrogen-rich water (1.0 L/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Waist circumference | Waist circumference, measured at the midpoint between the lower rib and iliac crest, serves as an indicator of abdominal adiposity and a key outcome reflecting metabolic risk. | Change from baseline waist circumference at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body fat | Body fat measured with bioimpedance analysis | Change from baseline body fat at 12 weeks |
| Lipoprotein (a) | Serum levels of lipoprotein (a) |
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Inclusion Criteria:
Age 30-65 years
Metabolic syndrome (NHS) (at least 3 of the 5 following criteria):
Not physically active
Informed consent signed
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Bioenergetics Lab at Faculty of Sport and PE | Novi Sad | Vojvodina | 21000 | Serbia |
Data obtained through this study may be provided to qualified researchers with academic interest in metabolic syndrome. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Only qualified researchers with academic interest in metabolic syndrome or molecular hydrogen research
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| Experimental 2: high-breath hydrogen | Dietary Supplement | Hydrogen-rich water (1.0 L/day) |
|
| Experimental 3: low-breath hydrogen | Dietary Supplement | Placebo water (1.0 L/day) |
|
| Experimental 4: high-breath hydrogen | Dietary Supplement | Placebo water (1.0 L/day) |
|
| Change from baseline lipoprotein (a) at 12 weeks |
| Total antioxidant capacity | Serum levels of total antioxidant capacity | Change from baseline total antioxidant capacity at 12 weeks |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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