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

Healthy Volunteers Clinical Trial

— FLORIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983086
• Other study ID #: CHU-0059
• Status: Completed
• Phase: Phase 1
• First received: September 22, 2009
• Last updated: September 22, 2009
• Start date: August 2007
• Est. completion date: April 2008

Study information

• Verified date: September 2009
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Institut National de la Recherche Agronomique

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the effects of repeated consumption of orange juice or purified flavanones in immune function		after consumption of orange juice	Yes
Secondary	Measuring the impact of consumption of orange juice or purified flavanones on acid-base balance		after consumption of orange juice	Yes
Secondary	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	Yes