Post-menopausal Status Clinical Trial
Official title:
Effects of a Long-term and Regular Grapefruit Juice Consumption on Vascular Protection and Bone Metabolism : a Cross-over Designed Study to Determine the Specific Role of Naringin
Epidemiological studies definitively show that fruit and vegetable consumption is an
important factor for the prevention of age-related diseases such as cardiovascular diseases
(CVD) and osteoporosis. Citrus fruits are among the fruits which are the most frequently
consumed worldwide, essentially as juices.
Citrus fruits are the exclusive sources of a particular class of dietary flavonoids, namely
flavanones. Grapefruit consumed as whole fruit or juice corresponds to a quantitatively
significant source of a specific flavanone called naringin.
Epidemiological studies definitively show that fruit and vegetable consumption is an
important factor for the prevention of age-related diseases such as cardiovascular diseases
(CVD) and osteoporosis. Citrus fruits are among the fruits which are the most frequently
consumed worldwide, essentially as juices.
Citrus fruits are the exclusive sources of a particular class of dietary flavonoids, namely
flavanones. Grapefruit consumed as whole fruit or juice corresponds to a quantitatively
significant source of a specific flavanone called naringin.
Some scientific data obtained from animal studies or in vitro experiments suggested that
flavanones could exert positive effects on several biomarkers of the cardiovascular or
osteoporosis risks. However, until now, the clinical proof of the efficacy of these
compounds is far to be obtained and more clinical trials are needed.
The main goals of this project are (1) to characterize the effect of a long-term grapefruit
juice consumption on both vascular and bone protections and (2) to assess the specific role
of naringin, in these potential protective effects.
To reach these goals, a randomized, cross-over clinical trial will be performed on 52
healthy post-menopausal women (50 to 65 years old, 3 to 10 years since menopause, waist > 88
cm). Such a population shares an increased risk of CVD and osteoporosis.
They will consume for two periods of 6 months either 340 ml of grapefruit juice or a control
isoenergetic beverage.
Major outcomes will be measured at baseline and at the end of each experimental period.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention