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

NCT01272167 | Completed

• 2 other identifiers: CHU-00852009-A00960-57
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-menopausal Status

Keywords

Post-menopausal women; Grapefruit juice; Naringin; Vascular protection; Bone metabolism

Interventions

Long-term grapefruit juice consumption BEHAVIORAL

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.

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• INRA de Clermont-Fd / Theix: collaborator
• UMR 1019 Unité de Nutrition Humaine: collaborator
• Equipe MiMes: collaborator
• 63122 Saint-Genès Champanelle: collaborator
• FRANCE: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (2)

• 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.

  PMID: 35694160 DERIVED

• 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.

  PMID: 26016866 DERIVED

Study Officials

• Claude DUBRAY

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 7, 2011
• Study Start: March 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

FR (1)