The Effect of Citric Flavonoid Administration on Endothelial Function and Gut Barrier Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Endothelial function
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Hormone replacement therapy (women)
- •Use of antibiotics in the 90 days prior to the start of study
- •Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study
- •Known pregnancy (assessed by a pregnancy test before start of study), lactation
- •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 the FMD measurements one day prior to test days.
- •History of any side effects towards the intake of flavonoids or citrus fruits
Arms & Interventions
Placebo
Cellulose
Intervention: Placebo (Dietary Supplement)
Citric flavonoid
Citric flavonoid
Intervention: Capsule containing citrus flavonoid (Dietary Supplement)
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
- Gut barrier function(6 weeks)
- Glucose / insulin metabolism(6 weeks)
- Endothelial function(6 weeks)
- Blood pressure & heart rate(6 weeks)
- Colonic inflammation(6 weeks)
- Bioavailability and metabolism(5 days)
- Lipid profile(6 weeks)
Investigators
Bouke Salden
Coordinating Investigator
Maastricht University Medical Center