metabolic syndrome obesity overweight
Conditions
Interventions
Participants will be randomly assigned to one of the intervention groups. One
group will receive one daily dose of 500 mg Cordiart*, while the other group
receives an identical looking placebo capsu
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Men/women, healthy human beings, age 18-65 and two of following criteria: *Waist circumference: men > 102 cm / women > 88 cm *Triglycerides: * 1.7 mmol/l *HDL-cholesterol: men * 1.0 mmol/l / women * 1.3 mmol/l *Systolic blood pressure: * 130 mmHg or diastolic blood pressure: * 85 mmHg *Fasted serum glucose * 6.1 mmol/L
Exclusion criteria
Exclusion criteria: Type 2 diabetes mellitus; gastroenterological diseases or abdominal surgery; cardiovascular diseases; cancer; liver or kidney malfunction; disease with life expectancy shorter than 5 years; self-admitted HIV-positive status; abuse of products such as alcohol (>20 alcoholic consumptions per week) or drugs; smoking; plans to lose weight or following a hypocaloric diet; weight gain or loss > 3 kg in previous 3 months; use of medication interfering with endpoints; use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets, or in alternative medicine; hormone replacement therapy; use of antibiotics in the 90 days prior to the start of he study; known pregnancy; lactation; history of side effects towards intake of flavonoids or citrus fruits; administration of investigational drugs or participating in any scientific intervention study which may interfere with this study (to be decided by principal investigator) in the 180 days prior to the study; blood donation within 3 months before study period; failure to comply prohibited intake of hesperidin containing food products during study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the efficacy of Cordiart* on glucose/insulin metabolism, as assessed by OGTT measurements, after 12 weeks of administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: - Determine the 12-week effect of Cordiart* on glucose/insulin metabolism by blood measurements (to calculate homeostasis model assessment of indulin resistance (HOMA-IR) and quantitative insulin sensitivity check index (QUICKI)) - Determine the 12-week effect of Cordiart* on lipid metabolism by blood measurements - Determine the 12-week effect of Cordiart* on body composition by anthropometric measurements (BMI, waist-hip circumference) - Determine the 12-week effect of Cordiart* on blood pressure and heart rate by measuring systolic and diastolic blood pressure and heart rate - Determine the 12-week effect of Cordiart* on plasma biomarkers of low-grade inflammation (TNF-*, IL-6, FFA, Adiponectin, MDA, Glutation) - Determine the 12-week effect of Cordiart* on gut barrier function by measuring plasma and fecal zonulin - Determine the 12-week effect of Cordiart* on gut barrier function by performing a sugar permeability test - Determine the 12-week effect of Cordiart* on microbiota composition | — |
Countries
Netherlands
Outcome results
None listed