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Completed

NCT Number: NCT00983086

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

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.

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Key information

Conditions

Age range

50 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: after consumption of orange juice

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Registry information

Acronym: FLORIDE

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 23, 2009
Registry last updated
Sep 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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