Clinical trial NCT01272167: Effects of a Long-term Grapefruit Juice Consumption on Vascular Protection and Bone Metabolism
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-menopausal Status
Keywords: Post-menopausal women
Grapefruit juice
Naringin
Vascular protection
Bone metabolism
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: INRA de Clermont-Fd / Theix
name: UMR 1019 Unité de Nutrition Humaine
name: Equipe MiMes
name: 63122 Saint-Genès Champanelle
name: FRANCE
First posted: 2011-01-07
Enrollment: 52
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Caucasian healthy post-menopausal women
* 19≤ BMI ≤29 and waist measurement \> 88 cm

Exclusion Criteria:

* Metabolic diseases
* Hypertension
* Taking CYP3A4-metabolized drugs
* Taking blood lipids lowering drugs or antihypertensive drugs
* Hypercholesterolemia with HDL \< 1.30 mmol/L (i.e. \< 0.5 g/L)
* Osteoporosis (defined by T-score of -2.5 SD at hip and/or lumbar spine)
* Taking hormone replacement therapy (HRT)
* Smokers
* Taking dietary supplements

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Claude DUBRAY
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krga I, Corral-Jara KF, Barber-Chamoux N, Dubray C, Morand C, Milenkovic D. Grapefruit Juice Flavanones Modulate the Expression of Genes Regulating Inflammation, Cell Interactions and Vascular Function in Peripheral Blood Mononuclear Cells of Postmenopausal Women. Front Nutr. 2022 May 26;9:907595. doi: 10.3389/fnut.2022.907595. eCollection 2022.
citation: Habauzit V, Verny MA, Milenkovic D, Barber-Chamoux N, Mazur A, Dubray C, Morand C. Flavanones protect from arterial stiffness in postmenopausal women consuming grapefruit juice for 6 mo: a randomized, controlled, crossover trial. Am J Clin Nutr. 2015 Jul;102(1):66-74. doi: 10.3945/ajcn.114.104646. Epub 2015 May 27.