Effects of Hesperidin on Bone Mineral Density and Bone Metabolism of Postmenopausal Women

October 28, 2015 updated by: Nestlé
Fruits and vegetables are rich in a variety of flavonoids with antioxidant properties. These compounds may be partially responsible for some of the positive links found between fruits and vegetables intake and higher bone mineral density in adults and children. Several animal studies have shown that consumption of onions (which are rich in quercetin), rutin (a quercetin glycoside) and resvatrol (found in red wine) inhibits ovariectomy induced bone loss in rats. One of the most studied flavonoids with respect to bone health is the soy isoflavones. However, consumption of soy products is relatively low in Western countries. One the other hand, a flavonoid such as hesperidin, found mostly in oranges is much more abundant in the Western diet. Citrus juice consumption has been demonstrated to prevent bone loss in male orchidectomized rats while specifically feeding hesperidin has been shown to prevent bone loss in ovariectomized mice and rats. However, to date no clinical prove has been obtained for these benefits.Therefore the aim of this study is to investigate the effect of hesperidin in preventing bone loss in postmenopausal women. This study is designed as a 2-year, double blind, placebo-controlled, two arm, and parallel group study. The primary outcome measure is change in bone mineral density (BMD) while the secondary outcome measures are changes in bone resorption and formation markers as well as body composition. The women are randomised to consume 2 servings of hesperidin-rich food or food without hesperidin but with the same taste & appearance (placebo). Subjects will undergo medical screening, anthropometry, physical activity, dietary assessments and BMD before randomisation into placebo or active group. Follow-up measurements are made at 3-month intervals (for blood and urine collection) and 6-month intervals for bone mineral density. Side effects are also being monitored during each visit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 3

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

  • France
    • Auvergne
      • Clermont-Ferrand, Auvergne, France, 63009
        • Centre de Recherche en Nutrition Humaine. Laboratoire de Nutrition Humaine

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 to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

50 - 65 years, Caucasian female Community dwelling women· Within 3-10 years post-menopause (natural or surgical) and FSH > 20UI/L· Generally healthy as determined by standard medical assessment on physical and mental health · Normal weight as determined by BMI (19≤ BMI ≤29)· Affiliated to National Health Insurance (Sécurité Sociale)· 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, malignancy, chronic malnutrition· Have had major gastrointestinal surgery· Osteoporosis (defined by T-score of £ -2.5 SD at hip and/or spine)· Very low BMD at hip and "and/or" spine, indicating high risk of osteoporosis (T-score £ -2.0 SD)· Severe scoliosis that could interfere with BMD measurements· 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. · On hormone replacement therapy (HRT) 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· Taking regular calcium (> 500 mg/day) and vitamin D (> 400 IU/day) supplements Hypercholesterolemia with HDL < 1,30 mmol/L (0,5 g/L)· Having a baseline calcium intake of below 800 mg/day and 25-OH vitamin D status of below 25 nmol/L or above 200 nmol/L· 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) and for pipe/cigars· Blood donation less than 3 months before the beginning of the study· Currently participating or having participated in another clinical trial during past 1 year prior to the beginning of this study, this depending on the type of previous study· Special dietary habits (vegetarians)· Phytoestrogens or antioxidants (dietary supplements) consumption· Physical activity > 10 hours / week

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hesperidin-rich food
Drug: Hesperidin
Placebo Comparator: No intervention: Placebo
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bone mineral density

Secondary Outcome Measures

Outcome Measure
Serum markers of bone resorption and bone formationChanges in body composition

Collaborators and Investigators

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

Sponsor

Nestlé

Collaborators

Institut National de la Recherche Agronomique
Centre de Recherche en Nutrition Humaine. Clermont-Ferrand, France

Investigators

  • Principal Investigator: Marie-Noelle Horcajada, PhD, INRA de Theix Laboratoire des Maladies Métaboliques et Micronutriments

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

March 1, 2006

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

May 24, 2006

First Submitted That Met QC Criteria

May 24, 2006

First Posted (Estimate)

May 25, 2006

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05.12NRC

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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