Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women

Study Overview
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Brief Summary
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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

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

Conditions
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Osteopenia, Osteoporosis

Intervention / Treatment
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* Other: Hesperidin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a<br>Active carrier 1: biscuit providing 250 mg hesperidin per piece(6g) | Other: Hesperidin<br>* 250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months<br>|
| Experimental: b<br>Active carrier 2: liquid skim milk providing 250 mg hesperidin/serve (200 ml) and containing around 300 mg calcium/serving | Other: Hesperidin<br>* 250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months<br>|
| Placebo Comparator: c<br>Placebo carrier 1: biscuit with the same nutrient composition and appearance as the active biscuit carrier but minus hesperidin | Other: Hesperidin<br>* 250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months<br>|
| Placebo Comparator: d<br>Placebo carrier 2: liquid skim milk with the same nutrient composition and appearance as the active milk carrier but minus hesperidin | Other: Hesperidin<br>* 250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full blood biochemistry analyses including lipid profile |  | 6 months | 
| Percentage change from baseline for osteoarthritis markers (CTX2 and others) |  | 6 months |