The effect of hesperidin administration on endothelial function and gut barrier functio
- Conditions
- verstoringen in intestinale barrierfunctiemetabolic syndromeobesityoverweight10047066
- Registration Number
- NL-OMON38722
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 68
Men/women, BMI 25-35 kg/m2, healthy human beings, age 18-70 years, fasting glucose <7.0 mmol/L, Hba1c between 4.4-6.2%
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to evaluate the efficacy of Cordiart* on<br /><br>endothelial function, as assessed by flow mediated dilatation (FMD)<br /><br>measurements, after 6 weeks of administration.</p><br>
- Secondary Outcome Measures
Name Time Method