Text Size

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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00539916
First received: October 4, 2007
Last updated: August 15, 2008
Last verified: August 2008
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Regular and Consequent Citrus Fruit Consumption on Vascular Protection Specific Role of the Component Phytomicronutrients

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipidic & glycemic balance, Polyphenols & carotenoid plasmatic concentration [ Time Frame: At the beginning and the end of each experimental period ] [ Designated as safety issue: No ]
  • Post-prandial lipemia [ Time Frame: At the end of each experimental period ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539916

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

Publications:

Responsible Party: Jean Pierre Leroy/Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00539916     History of Changes
Other Study ID Numbers: CHUBX 2007/03
Study First Received: October 4, 2007
Last Updated: August 15, 2008
Health Authority: France: Direction Générale de la Santé

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013