Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women
NCT ID: NCT00545116
Last Updated: 2015-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
144 participants
INTERVENTIONAL
2007-10-31
2012-01-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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a
Active carrier 1: biscuit providing 250 mg hesperidin per piece(6g)
Hesperidin
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
b
Active carrier 2: liquid skim milk providing 250 mg hesperidin/serve (200 ml) and containing around 300 mg calcium/serving
Hesperidin
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
c
Placebo carrier 1: biscuit with the same nutrient composition and appearance as the active biscuit carrier but minus hesperidin
Hesperidin
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
d
Placebo carrier 2: liquid skim milk with the same nutrient composition and appearance as the active milk carrier but minus hesperidin
Hesperidin
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
Interventions
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Hesperidin
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
FEMALE
Yes
Sponsors
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National University of Malaysia
OTHER
Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Winnie Chee, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Allied Health Sciences, UKM
Locations
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Hospital of UKM, National University of Malaysia
Kuala Lumpur, , Malaysia
Countries
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Other Identifiers
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Nestec 06.34
Identifier Type: -
Identifier Source: org_study_id
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