Status:
COMPLETED
Effects of Hesperidin on Bone Mineral Density and Bone Metabolism of Postmenopausal Women
Lead Sponsor:
Société des Produits Nestlé (SPN)
Collaborating Sponsors:
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Centre de Recherche en Nutrition Humaine. Clermont-Ferrand, France
Conditions:
Osteoporosis, Osteopenia
Eligibility:
FEMALE
50-65 years
Phase:
PHASE3
Brief Summary
Fruits and vegetables are rich in a variety of flavonoids with antioxidant properties. These compounds may be partially responsible for some of the positive links found between fruits and vegetables i...
Eligibility Criteria
Inclusion
- 50 - 65 years, Caucasian female Community dwelling women· Within 3-10 years post-menopause (natural or surgical) and FSH \> 20UI/L· Generally healthy as determined by standard medical assessment on physical and mental health · Normal weight as determined by BMI (19≤ BMI ≤29)· Affiliated to National Health Insurance (Sécurité Sociale)· Willing to comply with the study procedures· Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data· Having received both oral and written explanations about the study· Having provided her written informed consent
Exclusion
- ·Intestinal or severe metabolic diseases / disorders such as diabetes, renal, hepatic or pancreatic diseases / disorders, ulcer, hyperthyroidism, malignancy, chronic malnutrition· Have had major gastrointestinal surgery· Osteoporosis (defined by T-score of £ -2.5 SD at hip and/or spine)· Very low BMD at hip and "and/or" spine, indicating high risk of osteoporosis (T-score £ -2.0 SD)· Severe scoliosis that could interfere with BMD measurements· On therapy with drugs known to interfere with bone metabolism such as steroids, vitamin D or its derivatives, bisphosphonates, strontium ranelate, PTH, calcitonin, raloxifene, etc. · On hormone replacement therapy (HRT) previous 3 months before entering the study Taking medications containing hesperidin (e.g.Daflon) or known to interfere with hesperidin (statins, therapy for circulatory disorders, anti-depressants)Known to have allergic reactions to citrus-containing foods· Taking regular calcium (\> 500 mg/day) and vitamin D (\> 400 IU/day) supplements Hypercholesterolemia with HDL \< 1,30 mmol/L (0,5 g/L)· Having a baseline calcium intake of below 800 mg/day and 25-OH vitamin D status of below 25 nmol/L or above 200 nmol/L· Have an alcohol intake \> 2 glasses of wine per day (3dL/day), or \> 2 beers (3dL/d) or \> 1 shot glass of hard alcohol· Heavy smoker (more than 10 cigs a day) and for pipe/cigars· Blood donation less than 3 months before the beginning of the study· Currently participating or having participated in another clinical trial during past 1 year prior to the beginning of this study, this depending on the type of previous study· Special dietary habits (vegetarians)· Phytoestrogens or antioxidants (dietary supplements) consumption· Physical activity \> 10 hours / week
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00330096
Start Date
March 1 2006
End Date
April 1 2009
Last Update
October 29 2015
Active Locations (1)
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1
Centre de Recherche en Nutrition Humaine. Laboratoire de Nutrition Humaine
Clermont-Ferrand, Auvergne, France, 63009