Effects of Consumption of Orange Juice on Vascular Protection and Immune Function: Clinical Study on the Specific Contribution of Citrus Flavanones

Phase 1

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT00983086
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

Epidemiological studies have firmly established the health effects of high intakes of fruits and vegetables and in particular in regards to the prevention of cardiovascular diseases. Citrus fruits are the most widely consumed throughout the world, mainly as juice. Citrus fruits are rich in vitamin C but also in various plant micronutrients which are the most abundant polyphenols. Several in vitro studies and animal models suggest that the polyphenols of citrus are involved in the protective effects of citrus vis-à-vis the cardiovascular diseases. However, profits in health associated with taking these polyphenols are unknown and so far no clinical studies have been conducted to determine the contribution of polyphenols of citrus in this protection.

The main objectives of this project are (1) to characterize the effects of single dose and made repeated consumption of orange juice on vascular protection and the immune response and (2) to assess the specific role of polyphenols present in citrus fruits in this protection. To do this the investigators will conduct a clinical study, randomized and crossover, among healthy men 50 to 65 years that are slightly overweight. These volunteers, who continue to follow their usual diet, should consume daily for 4 weeks (1) orange juice or (2) an isocaloric control beverage or (3) the same drink spiked with a dose of polyphenols similar to that given by orange juice.

Detailed Description

Clinical study, randomized, crossover, double-blind in healthy men 50 to 65 years who are slightly overweight.

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2008-02
• Study Completion: 2008-04
• Status Verified: 2009-09
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Last Update Submitted: 2009-09-22
• Study First Posted: 2009-09-23
• Last Update Posted: 2009-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Males
• Age: 50 to 65 inclusive
• Body mass index of 25 to 30 kg / m² (inclusive

Exclusion Criteria

• Hypertriglyceridemia or known hypercholesterolemia, treated or not
• Serology HIV and / or HCV positive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Determine the effects of repeated consumption of orange juice or purified flavanones in immune function	after consumption of orange juice

Secondary Outcome Measures

Name	Time	Method
Measuring the impact of consumption of orange juice or purified flavanones on acid-base balance	after consumption of orange juice
Evaluate the effects of chronic consumption of orange juice or purified flavanones on gene expression by a global transcriptomic approach in mononuclear cells from peripheral blood	after consumption of orange juice