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

This study has been completed.
Information provided by:
University Hospital, Bordeaux Identifier:
First received: October 4, 2007
Last updated: August 15, 2008
Last verified: August 2008

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 Intervention
Cardiovascular Disease Risk Factors Behavioral: Regular orange juice consumption

Study Type: Interventional
Study Design: 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

Further study details as provided by University Hospital, Bordeaux:

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

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

Enrollment: 30
Study Start Date: October 2007
Study Completion Date: March 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Jus d'orange Behavioral: Regular orange juice consumption
600 mL /day.
Placebo Comparator: Boisson contrôle Behavioral: Regular orange juice consumption
600 mL /day.

  Show Detailed Description


Ages Eligible for Study:   50 Years to 65 Years   (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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00539916

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


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jean Pierre Leroy/Clinical Research and Innovation Director, University Hospital, Bordeaux Identifier: NCT00539916     History of Changes
Other Study ID Numbers: CHUBX 2007/03
Study First Received: October 4, 2007
Last Updated: August 15, 2008

Additional relevant MeSH terms:
Cardiovascular Diseases processed this record on August 22, 2017