The Effect of Citric Flavonoid on Endothelial Function

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Overweight

Obesity

Treatments

Dietary Supplement: Capsule containing citrus flavonoid

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02228291

13-3-019

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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
Smoking
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