Clinical trial NCT00545116: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteopenia
Osteoporosis
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: National University of Malaysia
First posted: 2007-10-17
Enrollment: 144
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers
timeFrame: Six months
Secondary outcomes:
measure: Full blood biochemistry analyses including lipid profile
timeFrame: 6 months
measure: Percentage change from baseline for osteoarthritis markers (CTX2 and others)
timeFrame: 6 months
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Hospital of UKM, National University of Malaysia
Study officials:
affiliation: Faculty of Allied Health Sciences, UKM
name: Winnie Chee, PhD
role: PRINCIPAL_INVESTIGATOR
References: