Effects of Hesperidin on Bone Mineral Density and Bone Metabolism of Postmenopausal Women
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ClinicalTrials.gov Identifier: NCT00330096 |
Recruitment Status :
Completed
First Posted : May 25, 2006
Last Update Posted : October 29, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis, Osteopenia | Drug: Hesperidin Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 110 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Study Start Date : | March 2006 |
Actual Study Completion Date : | April 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Hesperidin-rich food |
Drug: Hesperidin |
Placebo Comparator: No intervention: Placebo |
Other: Placebo |
- Bone mineral density
- Serum markers of bone resorption and bone formationChanges in body composition

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Ages Eligible for Study: | 50 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330096
France | |
Centre de Recherche en Nutrition Humaine. Laboratoire de Nutrition Humaine | |
Clermont-Ferrand, Auvergne, France, 63009 |
Principal Investigator: | Marie-Noelle Horcajada, PhD | INRA de Theix Laboratoire des Maladies Métaboliques et Micronutriments |
ClinicalTrials.gov Identifier: | NCT00330096 |
Other Study ID Numbers: |
05.12NRC |
First Posted: | May 25, 2006 Key Record Dates |
Last Update Posted: | October 29, 2015 |
Last Verified: | October 2013 |
bone loss, osteoporosis, prevention, hesperidin |
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |