Post-menopausal StatusNCT01272167
Effects of a Long-term Grapefruit Juice Consumption on Vascular Protection and Bone Metabolism
A study testing Long-term grapefruit juice consumption in people with Post-menopausal Status, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-menopausal Status
- What is being tested?
- Long-term grapefruit juice consumption
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian healthy post-menopausal women
- 19≤ BMI ≤29 and waist measurement > 88 cm
Who cannot join
- 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)
Show all 9Show fewer
- Taking hormone replacement therapy (HRT)
- Smokers
- Taking dietary supplements
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Post-menopausal Status
- Being tested
- Long-term grapefruit juice consumption
- Keywords
- Post-menopausal women, Grapefruit juice, Naringin, Vascular protection, Bone metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term grapefruit juice consumptionBehavioural
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-menopausal StatusStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- INRA de Clermont-Fd / Theix, UMR 1019 Unité de Nutrition Humaine, Equipe MiMes, 63122 Saint-Genès Champanelle, FRANCE
- Responsible party
- Sponsor
- Investigators
- Claude DUBRAY, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272167
- Sponsor's protocol ID
- CHU-0085
- Other IDs
- 2009-A00960-57
- Status last verified
- Jul 2026
- First submitted
- 3 Jan 2011
- Last updated
- 3 Aug 2026
- Results posted
- No
Publications
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.
PubMed 26016866Krga 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.
PubMed 35694160
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01272167
- Acronym / sponsor ID
- CHU-0085
- Conditions
- Post-menopausal Status
- Keywords
- Post-menopausal women, Grapefruit juice, Naringin, Vascular protection, Bone metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- INRA de Clermont-Fd / Theix, UMR 1019 Unité de Nutrition Humaine, Equipe MiMes, 63122 Saint-Genès Champanelle, FRANCE
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Caucasian healthy post-menopausal women
- 19≤ BMI ≤29 and waist measurement > 88 cm
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-term grapefruit juice consumptionThe 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. | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Results publication: PubMed 26016866Habauzit 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.
- Derived from this study: PubMed 35694160Krga 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude DUBRAY principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-term grapefruit juice consumption in people with Post-menopausal Status, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01272167, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.