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Treatment of post-menopausal subjects (with decreased bone mineral density) with pomegranate extract capsules will produce statistically significant changes in biomarkers for bone resorption and formation when compared to subjects receiving placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 POMx Capsules | Experimental | 2 POMx Capsules daily |
|
| 2 placebo Capsules | Placebo Comparator | 2 placebo Capsules daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 POMx Capsules | Dietary Supplement | 2 POMx Capsules daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers | To evaluate the impact of pomegranate extract capsules on urinary N-terminal telopeptide (NTX) and serum procollagen type 1 amino-terminal propeptide (P1NP), in post-menopausal women with decreased bone mineral density | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Incidence of adverse events Changes in vital signs or laboratory values | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SeaView Research, Inc. | Miami | Florida | 33126 | United States |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 2 placebo Capsules |
| Dietary Supplement |
2 placebo Capsules daily |
|