Hesperidin and Bone Health in Postmenopausal Women

Not Applicable

Completed

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Dietary Supplement: Hesperidin; Dietary Supplement: Hesperidin and Calcilock; Dietary Supplement: Control

• Registration Number: NCT01881204
• Lead Sponsor: 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.

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).

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-19
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• Women at least 4 years postmenopausal

Exclusion Criteria

• Medications affecting bone resorption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hesperidin	Hesperidin	Subjects will consume 4 cookies containing Hesperidin, 552mg, daily
Hesperidin and Calcilock	Hesperidin and Calcilock	Subjects will consume 4 cookies containing Hesperidin and Calcilock.
Control	Control	Subjects will consume 4 cookies daily without Hesperidin or Calcilock.

Primary Outcome Measures

Name	Time	Method
Elimination of 41Calcium in Urine.	50 days	Appearance of Ca41 in urine will be measured by Accelerator Mass Spectrometry to represent calcium that is being lost from the skeleton.

Trial Locations

Locations (1)

Purdue University; 🇺🇸 West Lafayette, Indiana, United States