The Effect of Citric Flavonoid on Endothelial Function

Not Applicable

Completed

• Conditions: Obesity; Overweight
• Interventions: Dietary Supplement: Capsule containing citrus flavonoid; Dietary Supplement: Placebo

• Registration Number: NCT02228291
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-08-27
• Study First Submitted QC: 2014-08-27
• Study First Posted: 2014-08-29
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-06
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Citric flavonoid	Capsule containing citrus flavonoid	Citric flavonoid
Placebo	Placebo	Cellulose

Primary Outcome Measures

Name	Time	Method
Endothelial function	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 Outcome Measures

Name	Time	Method
Glucose / insulin metabolism	6 weeks	The fourth secondary objective of this study is to determine the 6-week effect on glucose / insulin metabolism by blood measurements.
Endothelial function	6 weeks	The second secondary objective of this study is to determine the 6-week effect on plasma biomarkers of endothelial dysfunction and low-grade inflammation.
Blood pressure & heart rate	6 weeks	The third objective of this study is to assess the 6-week effect on blood pressure and heart rate by measuring systolic and diastolic blood pressure and heart rate.
Gut barrier function	6 weeks	The sixth secondary objective of this study is to assess the 6-week effect of on gut barrier function by performing a gut sugar permeability test.
Colonic inflammation	6 weeks	The seventh secondary objective of this study is to assess the 6-week effect on colonic inflammation, by measuring fecal calprotectin.
Bioavailability and metabolism	5 days	The eight 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 its metabolites.
Lipid profile	6 weeks	The fourth secondary objective of this study is to determine the 6-week effect on lipid profile by blood measurements.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands