Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women

Short-term Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women: a Randomized Placebo-controlled Trial

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

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