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The principal objective of this study is to examine whether the addition of 100 g dried plum to the diets of men, regardless of their bone status, positively influences their indices of bone turnover in comparison with their corresponding baseline values and the control regimen.
To test the bone protective properties of dried plum, 66 men (50 to 79 years of age) will receive either 100 g dried plum/day or a control regimen for 12 months. Both groups will receive 500 mg calcium and 400 IU vitamin D daily.
Evaluation will be based on analyses of bone mineral density at baseline, 6 and 12-months and serum and urine markers of bone formation and resorption at baseline and 3, 6, and 12-months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dried plum (100 g dried plum) | Experimental | Participants will receive 100 g dried plum daily plus 500 mg calcium and 300 IU vitamin D daily |
|
| Calcium and vitamin D | Placebo Comparator | Participants will receive 500 mg calcium and 300 IU vitamin D daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dried plum | Dietary Supplement | Dried plum |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bone biomarkers | TRAP5b, BAP, CTX, P1NP | changes from baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density | BMD by DXA | changes from baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shirin Hooshmand, PhD, RD | San Diego State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Exercise and Nutritional Sciences | San Diego | California | 92182 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34714130 | Derived | Hooshmand S, Gaffen D, Eisner A, Fajardo J, Payton M, Kern M. Effects of 12 Months Consumption of 100 g Dried Plum (Prunes) on Bone Biomarkers, Density, and Strength in Men. J Med Food. 2022 Jan;25(1):40-47. doi: 10.1089/jmf.2021.0080. Epub 2021 Oct 29. |
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| ID | Term |
|---|---|
| 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 |
|---|---|
| D002118 | Calcium |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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Subjects will be randomly assign to one of the arms.
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| Calcium and vitamin D |
| Dietary Supplement |
Calcium and vitamin D supplement |
|
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |