The Effect of Citric Flavonoid on Endothelial Function

Obesity Clinical Trial

Official title:

The Effect of Citric Flavonoid Administration on Endothelial Function and Gut Barrier Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228291
• Other study ID #: 13-3-019
• Status: Completed
• Phase: N/A
• First received: August 27, 2014
• Last updated: July 6, 2015
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Capsule containing citrus flavonoid

• Placebo

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function	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.	6 weeks	No
Secondary	Endothelial function	The second secondary objective of this study is to determine the 6-week effect on plasma biomarkers of endothelial dysfunction and low-grade inflammation.	6 weeks	No
Secondary	Blood pressure & heart rate	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.	6 weeks	No
Secondary	Glucose / insulin metabolism	The fourth secondary objective of this study is to determine the 6-week effect on glucose / insulin metabolism by blood measurements.	6 weeks	No
Secondary	Lipid profile	The fourth secondary objective of this study is to determine the 6-week effect on lipid profile by blood measurements.	6 weeks	No
Secondary	Gut barrier function	The fifth secondary objective of this study is to assess the acute and 6-week effect on gut barrier function by measuring plasma and fecal endotoxin (LPS) and zonulin.	6 weeks	No
Secondary	Gut barrier function	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.	6 weeks	No
Secondary	Colonic inflammation	The seventh secondary objective of this study is to assess the 6-week effect on colonic inflammation, by measuring fecal calprotectin.	6 weeks	No
Secondary	Bioavailability and metabolism	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.	5 days	No