Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women

October 5, 2015 updated by: Nestlé

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

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kuala Lumpur, Malaysia, 56000
        • Hospital of UKM, National University of Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: a
Active carrier 1: biscuit providing 250 mg hesperidin per piece(6g)
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
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
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
250 mg of hesperidin twice a day taken oraly in a biscuit or in milk for 6 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Winnie Chee, PhD, Faculty of Allied Health Sciences, UKM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

October 16, 2007

First Submitted That Met QC Criteria

October 16, 2007

First Posted (Estimate)

October 17, 2007

Study Record Updates

Last Update Posted (Estimate)

October 6, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • Nestec 06.34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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