Hesperidin and Bone Health in Postmenopausal Women
- Conditions
- Osteoporosis, Postmenopausal
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 12
- Women at least 4 years postmenopausal
- Medications affecting bone resorption
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Purdue University
🇺🇸West Lafayette, Indiana, United States
Purdue University🇺🇸West Lafayette, Indiana, United States