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
  Purpose

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

Condition Intervention Phase
Osteopenia
Osteoporosis
Other: Hesperidin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Short-term Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women: a Randomized Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 144
Study Start Date: October 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: a
Active carrier 1: biscuit providing 250 mg hesperidin per piece(6g)
Other: Hesperidin
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
Experimental: b
Active carrier 2: liquid skim milk providing 250 mg hesperidin/serve (200 ml) and containing around 300 mg calcium/serving
Other: Hesperidin
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
Placebo Comparator: c
Placebo carrier 1: biscuit with the same nutrient composition and appearance as the active biscuit carrier but minus hesperidin
Other: Hesperidin
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months
Placebo Comparator: d
Placebo carrier 2: liquid skim milk with the same nutrient composition and appearance as the active milk carrier but minus hesperidin
Other: Hesperidin
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545116

Locations
Malaysia
Hospital of UKM, National University of Malaysia
Kuala Lumpur, Malaysia, 56000
Sponsors and Collaborators
Nestlé
National University of Malaysia
Investigators
Principal Investigator: Winnie Chee, PhD Faculty of Allied Health Sciences, UKM
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00545116     History of Changes
Other Study ID Numbers: Nestec 06.34
Study First Received: October 16, 2007
Last Updated: January 28, 2014
Health Authority: Malaysia: Ministry of Health

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Osteoporosis
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 23, 2014