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Hesperidin and Bone Health in Postmenopausal Women (Hesperidin)

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ClinicalTrials.gov Identifier: NCT01881204
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
Nestec Ltd.
Information provided by (Responsible Party):
Berdine Martin, Purdue University

Brief Summary:
The primary objective of this clinical trial is to test hesperidin with and without CALCILOCK® for bone resorption suppressing effect in postmenopausal women. The secondary objective is the comparison between 41Ca technology and classical biomarker to evaluate bone resorption.

Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Dietary Supplement: Hesperidin and Calcilock Dietary Supplement: Hesperidin Dietary Supplement: Control Not Applicable

Detailed Description:

Subjects will participate in four phases of the study: Baseline of 50 days and three intervention phases which include 50 days receiving product followed by 50 days of recovery. The total duration of the study will be 350 days. If participant has not been previously labeled with 41Ca, a 150 day period is added to the study.

Hesperidin (552mg) and Calcilock® (amount per day: Calcium: 684 mg; Phosphorus: 282mg; Magnesium: 102mg; Zinc: 2.86mg; Vitamin C: 20 mg; Vitamin K1: 28µg; Vitamin D: 1.86µg) will be administered in the form of cookies (biscuit).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Hesperidin and Bone Health in Postmenopausal Women
Study Start Date : April 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: Hesperidin and Calcilock
Subjects will consume 4 cookies containing Hesperidin and Calcilock.
Dietary Supplement: Hesperidin and Calcilock
Hesperidin (552mg) and Calcilock® (amount per day: Calcium: 684 mg; Phosphorus: 282mg; Magnesium: 102mg; Zinc: 2.86mg; Vitamin C: 20 mg; Vitamin K1: 28µg; Vitamin D: 1.86µg) will be administered in the form of cookies (biscuit).

Experimental: Hesperidin
Subjects will consume 4 cookies containing Hesperidin, 552mg, daily
Dietary Supplement: Hesperidin
Hesperidin (552mg) will be administered in the form of cookies (biscuit).

Placebo Comparator: Control
Subjects will consume 4 cookies daily without Hesperidin or Calcilock.
Dietary Supplement: Control
Cookies without Hesperidin or Calcilock added.




Primary Outcome Measures :
  1. Elimination of 41Calcium in Urine. [ Time Frame: 50 days ]
    Appearance of Ca41 in urine will be measured by Accelerator Mass Spectrometry to represent calcium that is being lost from the skeleton.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women at least 4 years postmenopausal

Exclusion Criteria:

  • Medications affecting bone resorption

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): NCT01881204


Locations
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United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Nestec Ltd.
Investigators
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Principal Investigator: Connie M Weaver, Ph.D. Purdue University
Study Director: Berdine R Martin, PhD Purdue University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Berdine Martin, Research Scientist, Purdue University
ClinicalTrials.gov Identifier: NCT01881204     History of Changes
Other Study ID Numbers: 10.21.NRC
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Keywords provided by Berdine Martin, Purdue University:
Hesperidin
Osteoporosis
Bone Loss
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases