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RecruitingNCT06184646Updated Jul 1, 2026

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
Female
01

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.

Read the 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.

02

Conditions studied

  • Bone Disease, Metabolic

Keywords

  • Osteopenia
  • Prune
  • Functional food
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • No intervention
    Control (0 g prune/day)

    Participants only receive 500 mg calcium and 400 IU vitamin D daily for 24 months.

  • Experimental
    30 g prune/day

    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

Interventions

  • Dietary supplementPrune

    30 g of prune/day

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

06

Study locations

1 of 1 sites recruiting
  • San Diego State University
    San Diego, California 92182-7251, United States
    • Shirin Hooshmand, PhD, RD · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT06184646
Lead sponsor
San Diego State University
Responsible party
Sponsor
First posted
Dec 28, 2023
Start date
Mar 15, 2024
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jul 1, 2026

Study contacts

Shirin Hooshmand, PhD
Contact
shooshmand@sdsu.edu
619-594-6823
Shirin Hooshmand, PhD
principal investigator · San Diego State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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