Status:
COMPLETED
The Effect of Citric Flavonoid on Endothelial Function
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18-70 years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT02228291
Start Date
March 1 2014
End Date
December 1 2014
Last Update
July 8 2015
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229HX