- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00545116
Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women
October 5, 2015 updated by: Nestlé
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
144
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kuala Lumpur, Malaysia, 56000
- Hospital of UKM, National University of Malaysia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
48 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: a
Active carrier 1: biscuit providing 250 mg hesperidin per piece(6g)
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250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
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Experimental: b
Active carrier 2: liquid skim milk providing 250 mg hesperidin/serve (200 ml) and containing around 300 mg calcium/serving
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250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
|
Placebo Comparator: c
Placebo carrier 1: biscuit with the same nutrient composition and appearance as the active biscuit carrier but minus hesperidin
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250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
|
Placebo Comparator: d
Placebo carrier 2: liquid skim milk with the same nutrient composition and appearance as the active milk carrier but minus hesperidin
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250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers
Time Frame: Six months
|
Six months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Full blood biochemistry analyses including lipid profile
Time Frame: 6 months
|
6 months
|
Percentage change from baseline for osteoarthritis markers (CTX2 and others)
Time Frame: 6 months
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Winnie Chee, PhD, Faculty of Allied Health Sciences, UKM
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
October 16, 2007
First Submitted That Met QC Criteria
October 16, 2007
First Posted (Estimate)
October 17, 2007
Study Record Updates
Last Update Posted (Estimate)
October 6, 2015
Last Update Submitted That Met QC Criteria
October 5, 2015
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nestec 06.34
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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