Effects of Regular and Consequent Citrus Fruits Consumption on Vascular Protection

NCT00539916 | Completed

• 1 other identifier: CHUBX 2007/03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease Risk Factors

Outcome Measures

Primary Outcomes (1)

• Endothelial function measured by humeral artery vasodilatation technic

  At inclusion and at the end of each expirmental period

Secondary Outcomes (2)

• Lipidic & glycemic balance, Polyphenols & carotenoid plasmatic concentration

  At the beginning and the end of each experimental period

• Post-prandial lipemia

  At the end of each experimental period

Study Arms (2)

Jus d'orange

EXPERIMENTAL

Behavioral: Regular orange juice consumption

Boisson contrôle

PLACEBO COMPARATOR

Behavioral: Regular orange juice consumption

Interventions

Regular orange juice consumption BEHAVIORAL

600 mL /day.

Boisson contrôle; Jus d'orange

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Hopital Saint André - Service de Médecine Interne - Pathologie Vasculaire

Bordeaux, 33075, France

Location

Related Publications (17)

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  PMID: 25865966 DERIVED

Study Officials

• Joël CONSTANS, Pr

  Service de Médecine Interne - Pathologie Vasculaire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 5, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: March 1, 2008
• Last Updated: August 18, 2008

Record last verified: 2008-08

Locations

FR (1)