Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women
This study is currently recruiting participants.
Verified November 2012 by Nestlé
Sponsor:
Nestlé
Collaborator:
National University of Malaysia
Information provided by:
Nestlé
ClinicalTrials.gov Identifier:
NCT00545116
First received: October 16, 2007
Last updated: November 16, 2012
Last verified: November 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Osteopenia Osteoporosis |
Other: Hesperidin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Short-term Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women: a Randomized Placebo-controlled Trial |
Resource links provided by NLM:
Further study details as provided by Nestlé:
Primary Outcome Measures:
- Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers [ Time Frame: Six months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Full blood biochemistry analyses including lipid profile [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Percentage change from baseline for osteoarthritis markers (CTX2 and others) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 144 |
| Study Start Date: | October 2007 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: a
Active carrier 1: biscuit providing 250 mg hesperidin per piece(6g)
|
Other: Hesperidin
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
|
|
Experimental: b
Active carrier 2: liquid skim milk providing 250 mg hesperidin/serve (200 ml) and containing around 300 mg calcium/serving
|
Other: Hesperidin
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
|
Other: Hesperidin
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
|
Other: Hesperidin
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545116
Contacts
| Contact: Winnie Chee, PhD | +603 40405245 | wsschee@yahoo.co.uk |
Locations
| Malaysia | |
| Hospital of UKM, National University of Malaysia | Recruiting |
| Kuala Lumpur, Malaysia, 56000 | |
| Principal Investigator: Winnie Chee, PhD | |
Sponsors and Collaborators
Nestlé
National University of Malaysia
Investigators
| Principal Investigator: | Winnie Chee, PhD | Faculty of Allied Health Sciences, UKM |
More Information
No publications provided
| Responsible Party: | Dr Winnie Chee, National University of Malaysia |
| ClinicalTrials.gov Identifier: | NCT00545116 History of Changes |
| Other Study ID Numbers: | Nestec 06.34 |
| Study First Received: | October 16, 2007 |
| Last Updated: | November 16, 2012 |
| Health Authority: | Malaysia: Ministry of Health |
Additional relevant MeSH terms:
|
Bone Diseases, Metabolic Osteoporosis Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013