verstoringen in intestinale barrierfunctie 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 Cordiart* 500 mg while the other group
receives an identical looking placebo capsul
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Men/women, BMI 25-35 kg/m2, healthy human beings, age 18-70 years, fasting glucose
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 (intake of antihypertensive medication, statins, corticosteroids, NSAIDs, ciclosporin A, rifampicin is strictly forbidden); 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 study; known pregnancy, lactatation; 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 and prohibited intake of food products that are able to influence FMD measurements one day prior to test days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the efficacy of Cordiart* on endothelial function, as assessed by flow mediated dilatation (FMD) measurements, after 6 weeks of administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - The first secondary objective of this study is to determine the acute effect of CordiartTM on endothelial function, by performing Flow Mediated Dilatation (FMD). - The second secondary objective of this study is to determine the 6-week effect of CordiartTM on plasma biomarkers of endothelial dysfunction and low-grade inflammation. - The third objective of this study is to assess the 6-week effect of CordiartTM on blood pressure and heart rate by measuring systolic and diastolic blood pressure and heart rate. - The fourth secondary objective of this study is to determine the 6-week effect of CordiartTM on glucose and lipid metabolism by blood measurements. - The fifth secondary objective of this study is to assess the acute effect of CordiartTM on gut barrier function by measuring plasma endotoxin (LPS). - The sixth secondary objective of this study is to assess the 6-week effect of CordiartTM administration on gut barrier function by measuring plasma and fecal endotoxin (LPS) and zonulin. - The seventh secondary objective of this study is to assess the 6-week effect of CordiartTM administration on gut barrier function by performing a gut sugar permeability test. - The eighth secondary objective of this study is to assess the 6-week effect of CordiartTM on colonic inflammation, by measuring fecal calprotectin. - The ninth secondary objective of this study is to enlarge the understanding of the bioavailability and metabolism of this study product in human beings, by relating specific intestinal (microbial) metabolism with serum levels of hesperidin metabolites. | — |
Countries
Netherlands
Outcome results
None listed