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The primary objective of this study is to determine if 12 months of consuming 50 grams of dried plum daily will prevent bone loss or augment bone accrual of young adult oral contraceptive (OC) users.
Eligible participants will be assigned among three groups 1) control non-OC users, 2) control OC users, and 3) dried plum OC users. OC users will be randomly allocated to the dried plum OC group, which will consume 50 g dried plum daily for 12 months, or a control group, for which dried plums will not be allowed and no control food will be provided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prune group | Experimental | Oral contraceptive users will consume 50 grams prunes daily. |
|
| Oral contraceptive users | No Intervention | Oral contraceptive users will be monitored throughout the study period. | |
| Non oral contraceptive users | No Intervention | Non oral contraceptive users will be monitored throughout the study period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prune | Other | daily consumption of 50 grams prune. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in bone mineral density from baseline to 12 months | Bone density measurements with DXA | At baseline, at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months | Bone biomarkers measurements with ELISA | At baseline, at 6 months, at 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirin Hooshmand | San Diego | California | 92182-7251 | United States | ||
| School of Exercise and Nutritional Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39310666 | Derived | DeMasi T, Tsang M, Mueller J, Giltvedt K, Nguyen TN, Kern M, Hooshmand S. Prunes May Blunt Adverse Effects of Oral Contraceptives on Bone Health in Young Adult Women: A Randomized Clinical Trial. Curr Dev Nutr. 2024 Jul 18;8(9):104417. doi: 10.1016/j.cdnut.2024.104417. eCollection 2024 Sep. |
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| San Diego |
| California |
| 92182 |
| United States |