Effects of a Long-term Grapefruit Juice Consumption on Vascular Protection and Bone Metabolism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
INRA de Clermont-Fd / Theix
UMR 1019 Unité de Nutrition Humaine
Equipe MiMes
63122 Saint-Genès Champanelle
FRANCE
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01272167
First received: January 3, 2011
Last updated: January 6, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Post-menopausal Status
Behavioral: Long-term grapefruit juice consumption

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Estimated Enrollment: 52
Study Start Date: March 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Long-term grapefruit juice consumption
    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.
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

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272167

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
INRA de Clermont-Fd / Theix
UMR 1019 Unité de Nutrition Humaine
Equipe MiMes
63122 Saint-Genès Champanelle
FRANCE
Investigators
Principal Investigator: Claude DUBRAY University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01272167     History of Changes
Other Study ID Numbers: CHU-0085, 2009-A00960-57
Study First Received: January 3, 2011
Last Updated: January 6, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Post-menopausal women
Grapefruit juice
Naringin
Vascular protection
Bone metabolism

ClinicalTrials.gov processed this record on April 21, 2014