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NCT06184646NARecruiting

Elucidating the Minimal Effective Dose of Prunes for Bone Health in Postmenopausal Women

San Diego State University

Start Date

3/15/2024

Completion Date

12/1/2028

Summary

The objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women.

Detailed Description

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.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * Postmenopausal * BMD t-score is between 0.5 and 2 SD below the mean * Not on hormone replacement therapy (HRT) and/or other pharmacological agents known to affect bone for at least three months prior to initiation of the study Exclusion Criteria: * Women whose BMD t-score at any site falls below 2.5 SD of the mean * Subjects receiving endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism * Subjects who smoke cigarettes or vape * Regular consumption of dried plum or prune juice

Interventions

DIETARY_SUPPLEMENT

Prune

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Conditions

Bone Disease, Metabolic

Locations

San Diego State University

San Diego, California 92182-7251

United States