Osteopenia, Osteoporosis
Conditions
Brief summary
The primary objective of this clinical trial is to determine the effects of hesperidin on biochemical markers of bone in post-menopausal women. The secondary objectives are: * To investigate changes in bone formation and bone resorption markers in response to hesperidin intake * To compare the efficacy of hesperidin in a milk versus biscuit * To collect safety information of hesperidin consumption in a human trial
Interventions
OTHERHesperidin
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
Sponsors
National University of Malaysia
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Community dwelling women * More than 4 years post-menopause (natural or surgical) * Generally healthy as determined by standard medical assessment on physical and mental health * 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, malignance, chronic malnutrition * Have had major gastrointestinal surgery * 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. * Had sustained a fracture in the preceding 12 months * On hormone replacement therapy (HRT) in the 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 * Baseline calcium intake less than 500 mg/day * 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) * Special dietary habits (vegetarians) * Phytoestrogens or antioxidants (dietary supplements) consumption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers | Six months |
Secondary
| Measure | Time frame |
|---|---|
| Full blood biochemistry analyses including lipid profile | 6 months |
| Percentage change from baseline for osteoarthritis markers (CTX2 and others) | 6 months |
Countries
Malaysia
Outcome results
None listed