Clinical trial NCT00983086: Effects of Consumption of Orange Juice on Vascular Protection and Immune Function: Clinical Study on the Specific Contribution of Citrus Flavanones
Official title: Effects of Consumption of Orange Juice on Vascular Protection and Immune Function: Clinical Study on the Specific Contribution of Citrus Flavanones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Flavanones and vascular function
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
First posted: 2009-09-23
Enrollment: 24
Sex: MALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Determine the effects of repeated consumption of orange juice or purified flavanones in immune function
timeFrame: after consumption of orange juice
Secondary outcomes:
measure: Measuring the impact of consumption of orange juice or purified flavanones on acid-base balance
timeFrame: after consumption of orange juice
measure: 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
timeFrame: after consumption of orange juice
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Claude Dubray, PU PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milenkovic D, Deval C, Dubray C, Mazur A, Morand C. Hesperidin displays relevant role in the nutrigenomic effect of orange juice on blood leukocytes in human volunteers: a randomized controlled cross-over study. PLoS One. 2011;6(11):e26669. doi: 10.1371/journal.pone.0026669. Epub 2011 Nov 16.
citation: Morand C, Dubray C, Milenkovic D, Lioger D, Martin JF, Scalbert A, Mazur A. Hesperidin contributes to the vascular protective effects of orange juice: a randomized crossover study in healthy volunteers. Am J Clin Nutr. 2011 Jan;93(1):73-80. doi: 10.3945/ajcn.110.004945. Epub 2010 Nov 10.