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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01272167
Enrollment
52
Registered
2011-01-07
Start date
2010-03-01
Completion date
2011-12-01
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-menopausal Status

Keywords

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

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.

Interventions

BEHAVIORALLong-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.

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER
INRA de Clermont-Fd / Theix
CollaboratorUNKNOWN
UMR 1019 Unité de Nutrition Humaine
CollaboratorUNKNOWN
Equipe MiMes
CollaboratorUNKNOWN
63122 Saint-Genès Champanelle
CollaboratorUNKNOWN
FRANCE
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 65 Years
Healthy volunteers
Yes

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORClaude DUBRAY

University Hospital, Clermont-Ferrand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026