Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women

Phase 2

Completed

• Conditions: Osteoporosis; Osteopenia
• Interventions: Other: Hesperidin

• Registration Number: NCT00545116
• Lead Sponsor: Société des Produits Nestlé (SPN)

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-17
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2014-01
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
b	Hesperidin	Active carrier 2: liquid skim milk providing 250 mg hesperidin/serve (200 ml) and containing around 300 mg calcium/serving
a	Hesperidin	Active carrier 1: biscuit providing 250 mg hesperidin per piece(6g)
d	Hesperidin	Placebo carrier 2: liquid skim milk with the same nutrient composition and appearance as the active milk carrier but minus hesperidin
c	Hesperidin	Placebo carrier 1: biscuit with the same nutrient composition and appearance as the active biscuit carrier but minus hesperidin

Primary Outcome Measures

Name	Time	Method
Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers	Six months

Secondary Outcome Measures

Name	Time	Method
Full blood biochemistry analyses including lipid profile	6 months
Percentage change from baseline for osteoarthritis markers (CTX2 and others)	6 months

Trial Locations

Locations (1)

Hospital of UKM, National University of Malaysia; 🇲🇾 Kuala Lumpur, Malaysia