Clinical trial NCT02228291: The Effect of Citric Flavonoid on Endothelial Function
Official title: The Effect of Citric Flavonoid Administration on Endothelial Function and Gut Barrier Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Polyphenols
Endothelial function
Gut barrier function
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-08-29
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Endothelial function
timeFrame: 6 weeks
Secondary outcomes:
measure: Endothelial function
timeFrame: 6 weeks
measure: Blood pressure & heart rate
timeFrame: 6 weeks
measure: Glucose / insulin metabolism
timeFrame: 6 weeks
measure: Lipid profile
timeFrame: 6 weeks
measure: Gut barrier function
timeFrame: 6 weeks
measure: Gut barrier function
timeFrame: 6 weeks
measure: Colonic inflammation
timeFrame: 6 weeks
measure: Bioavailability and metabolism
timeFrame: 5 days
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Department of Internal Medicine, Division of Gastroenterology-Hepatology
name: A.A.M. Masclee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salden BN, Troost FJ, de Groot E, Stevens YR, Garces-Rimon M, Possemiers S, Winkens B, Masclee AA. Randomized clinical trial on the efficacy of hesperidin 2S on validated cardiovascular biomarkers in healthy overweight individuals. Am J Clin Nutr. 2016 Dec;104(6):1523-1533. doi: 10.3945/ajcn.116.136960. Epub 2016 Oct 26.