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| Name | Class |
|---|---|
| Nestec Ltd. | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hesperidin and Calcilock | Experimental | Subjects will consume 4 cookies containing Hesperidin and Calcilock. |
|
| Hesperidin | Experimental | Subjects will consume 4 cookies containing Hesperidin, 552mg, daily |
|
| Control | Placebo Comparator | Subjects will consume 4 cookies daily without Hesperidin or Calcilock. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hesperidin and Calcilock | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Connie M Weaver, Ph.D. | Purdue University | Principal Investigator |
| Berdine R Martin, PhD | Purdue University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Purdue University | West Lafayette | Indiana | 47907 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26751193 | Derived | 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. |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D006569 | Hesperidin |
| ID | Term |
|---|---|
| D044950 | Flavanones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| Hesperidin | Dietary Supplement | Hesperidin (552mg) will be administered in the form of cookies (biscuit). |
|
| Control | Dietary Supplement | Cookies without Hesperidin or Calcilock added. |
|
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |