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

Last updated: June 27, 2025
Sponsor: San Diego State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bone Diseases

Metabolic Disorders

Treatment

Prune

Clinical Study ID

NCT06184646
HS-2023-0243
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 knownto affect bone for at least three months prior to initiation of the study

Exclusion

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) orneuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influencebone and calcium metabolism

  • Subjects who smoke cigarettes or vape

  • Regular consumption of dried plum or prune juice

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Prune
Phase:
Study Start date:
March 15, 2024
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • San Diego State University

    San Diego, California 92182-7251
    United States

    Active - Recruiting

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