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The objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women.
Two hundred randomly assigned to one of two treatment groups: 1) 30 g prunes and 2) control (0 g prunes). Both groups received 500 mg calcium and 400 IU Vitamin D as a daily supplement. Blood samples are collected at baseline, 12 and 24 months to assess biomarkers of bone turnover. Physical activity recall and food records are obtained at baseline, 12 and 24 months to examine physical activity and dietary confounders as potential covariates. Dual-energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) will be completed at baseline, 12 and 24 months to examine bone mineral density and structure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (0 g prune/day) | No Intervention | Participants only receive 500 mg calcium and 400 IU vitamin D daily for 24 months. | |
| 30 g prune/day | Experimental | Participants receive 500 mg calcium and 400 IU vitamin D daily for 24 months and 30 g of prune daily for 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prune | Dietary Supplement | 30 g of prune/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in bone mineral density at 12 and 24 months | bone mineral density as assessed by dual energy x-ray absorptiometry | Baseline, 12 months, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months | bone specific alkaline phosphatase (BAP) as assessed with ELISA | Baseline, 12 months, and 24 months |
| Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shirin Hooshmand, PhD | Contact | 619-594-6823 | shooshmand@sdsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shirin Hooshmand, PhD | San Diego State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego State University | Recruiting | San Diego | California | 92182-7251 | 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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tartrate acid phosphatase-5b (TRAP5b) as assessed with ELISA |
| Baseline, 12 months, and 24 months |