Osteoporosis, Postmenopausal
Conditions
Keywords
Hesperidin, Osteoporosis, Bone Loss
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).
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).
Cookies without Hesperidin or Calcilock added.
Sponsors
Study design
Eligibility
Inclusion criteria
* Women at least 4 years postmenopausal
Exclusion criteria
* Medications affecting bone resorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States