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

This study has been completed.
Sponsor:
Collaborators:
INRA de Clermont-Fd / Theix
UMR 1019 Unité de Nutrition Humaine
Equipe MiMes
63122 Saint-Genès Champanelle
FRANCE
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01272167
First received: January 3, 2011
Last updated: July 4, 2014
Last verified: July 2014
  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:

Enrollment: 52
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272167

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
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: University Hospital, 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: July 4, 2014
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 November 20, 2014