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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 16, 2014