Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women

Osteoporosis Clinical Trial

Official title:

Short-term Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women: a Randomized Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545116
• Other study ID #: Nestec 06.34
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2007
• Last updated: October 5, 2015
• Start date: October 2007
• Est. completion date: January 2012

Study information

• Verified date: January 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis

Intervention

Other:
• Hesperidin
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months

Locations

Country	Name	City	State
Malaysia	Hospital of UKM, National University of Malaysia	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
Nestlé	National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers		Six months	No
Secondary	Full blood biochemistry analyses including lipid profile		6 months	Yes
Secondary	Percentage change from baseline for osteoarthritis markers (CTX2 and others)		6 months	No