Hesperidin and Bone Health in Postmenopausal Women
Hesperidin
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 17, 2013
CompletedFirst Posted
Study publicly available on registry
June 19, 2013
CompletedMay 17, 2018
May 1, 2018
1.5 years
June 17, 2013
May 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Elimination of 41Calcium in Urine.
Appearance of Ca41 in urine will be measured by Accelerator Mass Spectrometry to represent calcium that is being lost from the skeleton.
50 days
Study Arms (3)
Hesperidin and Calcilock
EXPERIMENTALSubjects will consume 4 cookies containing Hesperidin and Calcilock.
Hesperidin
EXPERIMENTALSubjects will consume 4 cookies containing Hesperidin, 552mg, daily
Control
PLACEBO COMPARATORSubjects will consume 4 cookies daily without Hesperidin or Calcilock.
Interventions
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).
Hesperidin (552mg) will be administered in the form of cookies (biscuit).
Eligibility Criteria
You may qualify if:
- Women at least 4 years postmenopausal
You may not qualify if:
- Medications affecting bone resorption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Universitylead
- Nestec Ltd.collaborator
Study Sites (1)
Purdue University
West Lafayette, Indiana, 47907, United States
Related Publications (1)
Martin BR, McCabe GP, McCabe L, Jackson GS, Horcajada MN, Offord-Cavin E, Peacock M, Weaver CM. Effect of Hesperidin With and Without a Calcium (Calcilock) Supplement on Bone Health in Postmenopausal Women. J Clin Endocrinol Metab. 2016 Mar;101(3):923-7. doi: 10.1210/jc.2015-3767. Epub 2016 Jan 11.
PMID: 26751193DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Connie M Weaver, Ph.D.
Purdue University
- STUDY DIRECTOR
Berdine R Martin, PhD
Purdue University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
June 17, 2013
First Posted
June 19, 2013
Study Start
April 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
May 17, 2018
Record last verified: 2018-05