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NCT01881204 Clinical Trial

Hesperidin and Bone Health in Postmenopausal Women

Osteoporosis, Postmenopausal Clinical Trial

— Hesperidin  

Official title:
Hesperidin and Bone Health in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01881204
Other study ID # 10.21.NRC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2011
Est. completion date October 2012

Study information
Verified date May 2018
Source Purdue University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Women at least 4 years postmenopausal

Exclusion Criteria:

- Medications affecting bone resorption

Study Design

Related Conditions & MeSH terms

Intervention

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).
• Hesperidin
Hesperidin (552mg) will be administered in the form of cookies (biscuit).
• Control
Cookies without Hesperidin or Calcilock added.

Locations
Country Name City State
United States Purdue University West Lafayette Indiana

Sponsors (2)
Lead Sponsor Collaborator
Purdue University Nestec Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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