The Effect of Citric Flavonoid Administration on Endothelial Function and Gut Barrier Function
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Endothelial function
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This randomized, double-blind, placebo-controlled, parallel study aims to determine the 6-week and acute effects of daily administration of a citrus flavonoid on cardiovascular and intestinal health as assessed by investigation of endothelial function, blood pressure and heart rate, glucose/insulin metabolism, lipid profile and gut barrier function in overweigh subjects.
Futhermore we aim to relate the specific intestinal (microbial) metabolism with final serum levels of specific metabolites of the study product.
Investigators
Bouke Salden
Coordinating Investigator
Maastricht University Medical Center
Eligibility Criteria
Inclusion Criteria
- •Overweight men/women (BMI 25-35 kg/m2)
- •Healthy individuals
- •Age between 18 and 70 years
- •Fasting glucose \< 7.0 mmol/L
- •Normal HbA1c (4.4 to 6.2%)
Exclusion Criteria
- •Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L)
- •Gastroenterological diseases or abdominal surgery
- •Cardiovascular diseases, cancer, liver or kidney malfunction, thyroid disorders, disease with a life expectancy shorter than 5 years
- •Self-admitted HIV-positive status
- •Abuse of products; alcohol (\> 20 alcoholic consumptions per week) and drugs
- •Plans to lose weight or following a hypocaloric diet during the study period
- •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 are strictly forbidden
- •Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
Outcomes
Primary Outcomes
Endothelial function
Time Frame: 6 weeks
The primary objective of this study is to evaluate the efficacy on endothelial function, as assessed by flow mediated dilatation (FMD) measurements, after 6 weeks of administration of study product.
Secondary Outcomes
- Glucose / insulin metabolism(6 weeks)
- Endothelial function(6 weeks)
- Blood pressure & heart rate(6 weeks)
- Gut barrier function(6 weeks)
- Colonic inflammation(6 weeks)
- Bioavailability and metabolism(5 days)
- Lipid profile(6 weeks)