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

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ClinicalTrials.gov Identifier: NCT00983086
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : September 23, 2009
Sponsor:
Collaborator:
Institut National de la Recherche Agronomique
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Flavanones of orange juice Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effects of Consumption of Orange Juice on Vascular Protection and Immune Function: Clinical Study on the Specific Contribution of Citrus Flavanones
Study Start Date : August 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : April 2008

Intervention Details:
  • Drug: Flavanones of orange juice
    The main objective of this study is to evaluate, in healthy volunteers with young children (50 and 65) and slightly overweight according to their usual diet, the effects of single dose (in postprandial period) and made repeated orange juice or orange flavanones purified on vascular function. The selection criteria for age and weight should, within a healthy population to select individuals who exhibit cardiovascular risk factors, and thus for which it should be a priori easier to identify a beneficial effect of dietary factors on the parameters associated with cardiovascular risk.


Primary Outcome Measures :
  1. Determine the effects of repeated consumption of orange juice or purified flavanones in immune function [ Time Frame: after consumption of orange juice ]

Secondary Outcome Measures :
  1. Measuring the impact of consumption of orange juice or purified flavanones on acid-base balance [ Time Frame: after consumption of orange juice ]
  2. 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 [ Time Frame: after consumption of orange juice ]


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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983086


Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Institut National de la Recherche Agronomique
Investigators
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Principal Investigator: Claude Dubray, PU PH University Hospital, Clermont-Ferrand
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Patrick Lacarin, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00983086    
Other Study ID Numbers: CHU-0059
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: September 23, 2009
Last Verified: September 2009
Keywords provided by University Hospital, Clermont-Ferrand:
Flavanones and vascular function