Metabolic Syndrome
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTExperimental 1: low-breath hydrogen
Hydrogen-rich water (1.0 L/day)
DIETARY_SUPPLEMENTExperimental 2: high-breath hydrogen
Hydrogen-rich water (1.0 L/day)
DIETARY_SUPPLEMENTExperimental 3: low-breath hydrogen
Placebo water (1.0 L/day)
DIETARY_SUPPLEMENTExperimental 4: high-breath hydrogen
Placebo water (1.0 L/day)
Sponsors
University of Novi Sad, Faculty of Sport and Physical Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 30-65 years * Metabolic syndrome (NHS) (at least 3 of the 5 following criteria): * Waist circumference of ≥ 102 cm in men and ≥ 88 cm in women * Hypertriglyceridemia (≥ 1.695 mmol/L) * Low HDL-C (\< 1.04 mmol/dL in men and \< 1.30 mmol/dL in women) * High blood pressure (\> 130/85 mmHg) * High fasting glucose (\> 6.1 mmol/L) * Not physically active * Informed consent signed
Exclusion criteria
* Major chronic disease and acute injuries * History of dietary supplement use during the past 4 weeks * History of metabolism-modulating pharmaceuticals use during the past 4 weeks * No consent to randomization * Participation in other studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | Change from baseline waist circumference at 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body fat | Change from baseline body fat at 12 weeks | Body fat measured with bioimpedance analysis |
| Lipoprotein (a) | Change from baseline lipoprotein (a) at 12 weeks | Serum levels of lipoprotein (a) |
| Total antioxidant capacity | Change from baseline total antioxidant capacity at 12 weeks | Serum levels of total antioxidant capacity |
Countries
Serbia
Outcome results
None listed