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Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00545116
First Posted: October 17, 2007
Last Update Posted: October 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National University of Malaysia
Information provided by (Responsible Party):
Nestlé
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Short-term Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women: a Randomized Placebo-controlled Trial

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 ]

Secondary Outcome 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00545116     History of Changes
Other Study ID Numbers: Nestec 06.34
First Submitted: October 16, 2007
First Posted: October 17, 2007
Last Update Posted: October 6, 2015
Last Verified: January 2014

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