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Effects of Regular and Consequent Citrus Fruits Consumption on Vascular Protection (AGRUVASC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00539916
Recruitment Status : Completed
First Posted : October 5, 2007
Last Update Posted : August 18, 2008
Information provided by:
University Hospital, Bordeaux

Brief Summary:

Epidemiological studies definitively show that fruit and vegetable consumption is positive for health and more specifically for cardiovascular diseases (CVD) prevention. In France, among fruits, those which are the most frequently consumed are citrus fruits essentially as juices and more specifically as orange juices. However, their health effects have been poorly studied so far. Citrus fruits contain vitamin C associated with various phytomicronutrients i.e. carotenoids (essentially -cryptoxanthin) and polyphenols. Each fruit contains specific compounds: hesperetin in orange, naringenin in grapefruit, eriodyctiol in lemon. Some scientific studies performed either in vitro or in animal models demonstrated properties of these micronutrients which could contribute to a positive health effect of citrus fruits on vascular protection. However data are still missing.

The main goal of this project is to characterize the effect of orange juice consumption on vascular disease risk factors and to evaluate the specific role of their micronutrient compounds (polyphenols and carotenoids) in this protection. To reach this goal, a randomized "cross-over" clinical study will be performed on volunteers presenting a mild hypercholesterolemia. They will consume for 4 weeks an orange juice or a reconstituted drink similar to the orange juice for its composition in carbohydrates, minerals, vitamin C and folates but without phytomicronutrients. The effect of the juice consumption on the vascular function will be monitored exploring lipid abnormalities in plasma, measuring endothelial vasoreactivity (FMD) (Flow Mediated Dilatation), as well as endothelial dysfunction, thrombosis, inflammation and oxidative stress biomarkers in plasma. Comparison of urinary metabolomes after orange juice consumption or that of the reconstituted drink will lead to the identification of the metabolic pathways modulated by the orange juice micronutrients.

Moreover ELISA tests for the two major flavanones from citrus fruits (hesperetin and naringenin) will be developed. They will be used to determine the plasma levels of these molecules in order to analyze the relation "ingested quantity - bioavailable quantity - physiological effect".

The results obtained in this project will allow clarifying citrus fruit effects, and particularly orange juice, in vascular protection.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Risk Factors Behavioral: Regular orange juice consumption Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Regular and Consequent Citrus Fruit Consumption on Vascular Protection Specific Role of the Component Phytomicronutrients
Study Start Date : October 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : March 2008

Arm Intervention/treatment
Experimental: Jus d'orange Behavioral: Regular orange juice consumption
600 mL /day.

Placebo Comparator: Boisson contrôle Behavioral: Regular orange juice consumption
600 mL /day.

Primary Outcome Measures :
  1. Endothelial function measured by humeral artery vasodilatation technic [ Time Frame: At inclusion and at the end of each expirmental period ]

Secondary Outcome Measures :
  1. Lipidic & glycemic balance, Polyphenols & carotenoid plasmatic concentration [ Time Frame: At the beginning and the end of each experimental period ]
  2. Post-prandial lipemia [ Time Frame: At the end of each experimental period ]

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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

Inclusion Criteria:

  • 1.6 < LDL-Cholesterol < 1.9 g/L
  • Informed consent signed
  • Social security affiliation

Exclusion Criteria:

  • Tobacco
  • Hypertension
  • Diabetes
  • Renal or hepatic failure
  • Thyroid disease
  • Autoimmune disease
  • Inflammatory, infectious, or surgical event in the last three months
  • Antibiotics, laxative, diuretics
  • Vitamins, minerals, polyphenol, carotenoid supplementation in the last three months
  • Vegetarian
  • Sport : > 5h/week
  • High consumption of beverage rich in polyphenols (coffee, wine, fruit juice,...)
  • Intestinal disease
  • Alcoholism

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 identifier (NCT number): NCT00539916

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Hopital Saint André - Service de Médecine Interne - Pathologie Vasculaire
Bordeaux, France, 33075
Sponsors and Collaborators
University Hospital, Bordeaux
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Principal Investigator: Joël CONSTANS, Pr Service de Médecine Interne - Pathologie Vasculaire

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jean Pierre Leroy/Clinical Research and Innovation Director, University Hospital, Bordeaux Identifier: NCT00539916    
Other Study ID Numbers: CHUBX 2007/03
First Posted: October 5, 2007    Key Record Dates
Last Update Posted: August 18, 2008
Last Verified: August 2008
Additional relevant MeSH terms:
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Cardiovascular Diseases