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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00330096 |
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Date of registration:
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24/05/2006 |
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Primary sponsor: |
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Public title:
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Effects of Hesperidin on Bone Mineral Density and Bone Metabolism of Postmenopausal Women
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Scientific title:
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Date of first enrolment:
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March 2006 |
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Target sample size:
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110 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00330096 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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Countries of recruitment
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France
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Contacts
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Name:
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Marie-Noelle Horcajada, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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INRA de Theix Laboratoire des Maladies Métaboliques et Micronutriments |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
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 Criteria:
·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
Age minimum:
50 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Osteoporosis, Osteopenia
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Intervention(s)
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Drug: Hesperidin
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Primary Outcome(s)
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Bone mineral density
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Secondary Outcome(s)
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Serum markers of bone resorption and bone formationChanges in body composition
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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