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

NCT00983086 | Completed Phase 1

• 1 other identifier: CHU-0059
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteers

Keywords

Flavanones and vascular function

Outcome Measures

Primary Outcomes (1)

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

  after consumption of orange juice

Secondary Outcomes (2)

• 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

Interventions

Flavanones of orange juice DRUG

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.

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator

Related Publications (2)

• 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.

  PMID: 22110589 DERIVED

• 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.

  PMID: 21068346 DERIVED

Study Officials

• Claude Dubray, PU PH

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: August 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: April 1, 2008
• Last Updated: September 23, 2009

Record last verified: 2009-09