Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women

Overview

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

Full Title of Study: “Short-term Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women: a Randomized Placebo-controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2012

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Société des Produits Nestlé (SPN)
  • Collaborator
    • National University of Malaysia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Winnie Chee, PhD, Principal Investigator, Faculty of Allied Health Sciences, UKM

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