Back to resultsEffects of Hesperidin on Bone Biomarkers in Postmenopausal Women
Primary Purpose
Osteopenia, Osteoporosis
Status
Completed
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Hesperidin
Sponsored by
About this trial
This is an interventional prevention trial for Osteopenia
Eligibility 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
Sites / Locations
- Hospital of UKM, National University of Malaysia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
a
b
c
d
Arm Description
Active carrier 1: biscuit providing 250 mg hesperidin per piece(6g)
Active carrier 2: liquid skim milk providing 250 mg hesperidin/serve (200 ml) and containing around 300 mg calcium/serving
Placebo carrier 1: biscuit with the same nutrient composition and appearance as the active biscuit carrier but minus hesperidin
Placebo carrier 2: liquid skim milk with the same nutrient composition and appearance as the active milk carrier but minus hesperidin
Outcomes
Primary Outcome Measures
Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers
Secondary Outcome Measures
Full blood biochemistry analyses including lipid profile
Percentage change from baseline for osteoarthritis markers (CTX2 and others)
Full Information
NCT ID
NCT00545116
First Posted
October 16, 2007
Last Updated
October 5, 2015
Sponsor
Société des Produits Nestlé (SPN)
Collaborators
National University of Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT00545116
Brief Title
Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women
Official Title
Short-term Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women: a Randomized Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
Collaborators
National University of Malaysia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia, Osteoporosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
a
Arm Type
Experimental
Arm Description
Active carrier 1: biscuit providing 250 mg hesperidin per piece(6g)
Arm Title
b
Arm Type
Experimental
Arm Description
Active carrier 2: liquid skim milk providing 250 mg hesperidin/serve (200 ml) and containing around 300 mg calcium/serving
Arm Title
c
Arm Type
Placebo Comparator
Arm Description
Placebo carrier 1: biscuit with the same nutrient composition and appearance as the active biscuit carrier but minus hesperidin
Arm Title
d
Arm Type
Placebo Comparator
Arm Description
Placebo carrier 2: liquid skim milk with the same nutrient composition and appearance as the active milk carrier but minus hesperidin
Intervention Type
Other
Intervention Name(s)
Hesperidin
Intervention Description
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
Primary Outcome Measure Information:
Title
Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Full blood biochemistry analyses including lipid profile
Time Frame
6 months
Title
Percentage change from baseline for osteoarthritis markers (CTX2 and others)
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winnie Chee, PhD
Organizational Affiliation
Faculty of Allied Health Sciences, UKM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of UKM, National University of Malaysia
City
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
12. IPD Sharing Statement
Learn more about this trial
Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women
We'll reach out to this number within 24 hrs