Effects of Hesperidin on Bone Mineral Density and Bone Metabolism of Postmenopausal Women
Osteoporosis, Osteopenia
About this trial
This is an interventional prevention trial for Osteoporosis, Osteopenia focused on measuring bone loss, osteoporosis, prevention, hesperidin
Eligibility Criteria
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
Sites / Locations
- Centre de Recherche en Nutrition Humaine. Laboratoire de Nutrition Humaine
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Hesperidin-rich food
No intervention: Placebo