Healthy Volunteers
Conditions
Keywords
Flavanones and vascular function
Brief summary
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.
Detailed description
Clinical study, randomized, crossover, double-blind in healthy men 50 to 65 years who are slightly overweight.
Interventions
DRUGFlavanones of orange juice
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.
Sponsors
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
50 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the effects of repeated consumption of orange juice or purified flavanones in immune function | after consumption of orange juice |
Secondary
| Measure | Time frame |
|---|---|
| Measuring the impact of consumption of orange juice or purified flavanones on acid-base balance | after consumption of orange juice |
| 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 | after consumption of orange juice |
Outcome results
None listed