Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women

This study has been completed.
Sponsor:
Collaborator:
National University of Malaysia
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT00545116
First received: October 16, 2007
Last updated: January 28, 2014
Last verified: January 2014

October 16, 2007
January 28, 2014
October 2007
January 2012   (final data collection date for primary outcome measure)
Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers [ Time Frame: Six months ] [ Designated as safety issue: No ]
Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers [ Time Frame: Six months ]
Complete list of historical versions of study NCT00545116 on ClinicalTrials.gov Archive Site
  • Full blood biochemistry analyses including lipid profile [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Percentage change from baseline for osteoarthritis markers (CTX2 and others) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women
Short-term Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women: a Randomized Placebo-controlled Trial

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Osteopenia
  • Osteoporosis
Other: Hesperidin
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
  • Experimental: a
    Active carrier 1: biscuit providing 250 mg hesperidin per piece(6g)
    Intervention: Other: Hesperidin
  • Experimental: b
    Active carrier 2: liquid skim milk providing 250 mg hesperidin/serve (200 ml) and containing around 300 mg calcium/serving
    Intervention: Other: Hesperidin
  • Placebo Comparator: c
    Placebo carrier 1: biscuit with the same nutrient composition and appearance as the active biscuit carrier but minus hesperidin
    Intervention: Other: 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
    Intervention: Other: Hesperidin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Female
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Malaysia
 
NCT00545116
Nestec 06.34
No
Nestlé
Nestlé
National University of Malaysia
Principal Investigator: Winnie Chee, PhD Faculty of Allied Health Sciences, UKM
Nestlé
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP