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Hesperidin and Bone Health in Postmenopausal Women (Hesperidin)

Primary Purpose

Osteoporosis, Postmenopausal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hesperidin and Calcilock
Hesperidin
Control
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis, Postmenopausal focused on measuring Hesperidin, Osteoporosis, Bone Loss

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women at least 4 years postmenopausal

Exclusion Criteria:

  • Medications affecting bone resorption

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Hesperidin and Calcilock

Hesperidin

Control

Arm Description

Subjects will consume 4 cookies containing Hesperidin and Calcilock.

Subjects will consume 4 cookies containing Hesperidin, 552mg, daily

Subjects will consume 4 cookies daily without Hesperidin or Calcilock.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 17, 2013
Last Updated
May 14, 2018
Sponsor
Purdue University
Collaborators
Nestec Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01881204
Brief Title
Hesperidin and Bone Health in Postmenopausal Women
Acronym
Hesperidin
Official Title
Hesperidin and Bone Health in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Nestec Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
Keywords
Hesperidin, Osteoporosis, Bone Loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hesperidin and Calcilock
Arm Type
Experimental
Arm Description
Subjects will consume 4 cookies containing Hesperidin and Calcilock.
Arm Title
Hesperidin
Arm Type
Experimental
Arm Description
Subjects will consume 4 cookies containing Hesperidin, 552mg, daily
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Subjects will consume 4 cookies daily without Hesperidin or Calcilock.
Intervention Type
Dietary Supplement
Intervention Name(s)
Hesperidin and Calcilock
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Hesperidin
Intervention Description
Hesperidin (552mg) will be administered in the form of cookies (biscuit).
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
Cookies without Hesperidin or Calcilock added.
Primary Outcome Measure Information:
Title
Elimination of 41Calcium in Urine.
Description
Appearance of Ca41 in urine will be measured by Accelerator Mass Spectrometry to represent calcium that is being lost from the skeleton.
Time Frame
50 days

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women at least 4 years postmenopausal Exclusion Criteria: Medications affecting bone resorption
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie M Weaver, Ph.D.
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Berdine R Martin, PhD
Organizational Affiliation
Purdue University
Official's Role
Study Director
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26751193
Citation
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.
Results Reference
derived

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Hesperidin and Bone Health in Postmenopausal Women

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