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Clinical Trials/NCT00983086
NCT00983086
Completed
Phase 1

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

University Hospital, Clermont-Ferrand0 sites24 target enrollmentAugust 2007

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Healthy Volunteers
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
24
Primary Endpoint
Determine the effects of repeated consumption of orange juice or purified flavanones in immune function
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2007
End Date
April 2008
Last Updated
16 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Sponsor
University Hospital, Clermont-Ferrand

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Determine the effects of repeated consumption of orange juice or purified flavanones in immune function

Time Frame: after consumption of orange juice

Secondary Outcomes

  • 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)

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