An interventional study of Prune in Bone Disease, Metabolic, sponsored by San Diego State University. Recruiting at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by San Diego State University · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
Participants only receive 500 mg calcium and 400 IU vitamin D daily for 24 months.
Participants receive 500 mg calcium and 400 IU vitamin D daily for 24 months and 30 g of prune daily for 24 months.
Dietary Supplement: Prune
30 g of prune/day
Changes from baseline in bone mineral density at 12 and 24 months
bone mineral density as assessed by dual energy x-ray absorptiometry
Time frame: Baseline, 12 months, and 24 months
Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months
bone specific alkaline phosphatase (BAP) as assessed with ELISA
Time frame: Baseline, 12 months, and 24 months
Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months
tartrate acid phosphatase-5b (TRAP5b) as assessed with ELISA
Time frame: Baseline, 12 months, and 24 months
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San Diego State University