ClinicalTrials.gg
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

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 217 studies in Bone Diseases, Metabolic with a site in United States — 16 open to participants now, 21 under way, 1 of them phase 3. Bone Diseases, Metabolic · United States.

Planned enrollment
34th of 171
200 · median 66
Started
2024
with 3 others
No phase
57 of 217
6 open now
Primary completion
2028-12
later than 17 of 20 live
Registered
211th of 217
by date

Among the 217 studies in Bone Diseases, Metabolic with a site in United States, this one is the 34th largest by planned enrollment of the 171 interventional ones that give a count, is one of 4 that started in 2024, is one of 57 with no phase, reaches primary completion later than 17 of the 20 other live ones, and was the 211th registered.

Bone Diseases, Metabolic

661 studies on the registry are indexed under Bone Diseases, Metabolic; 93 are open to participants now.

Browse Bone Diseases, Metabolic studies →

Open to participants now

16 of the 217 studies in Bone Diseases, Metabolic with a site in United States are open now. Recruiting first, the newest first:

10 more — sign in →

All 16 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 63 Bone Diseases, Metabolic studies recruiting now, 27 (43%) set no upper age limit and 28 (44%) stop at 75 or younger; 12 take children under 18; 22 take healthy volunteers.

This study: female · no healthy volunteers.

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02

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.

03

Conditions studied

  • Bone Disease, Metabolic

Keywords

  • Osteopenia
  • Prune
  • Functional food
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 ) 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

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

06

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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Dec 2028, 57 months after the start.

Of 161 non-industry interventional studies with no phase under Bone Diseases, Metabolic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 57 months is above that.

Counting every sponsor, half of 177 studies reached it within 22 months; a quarter within 10 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2023
First posted
Dec 28, 2023
StartActual
Mar 15, 2024
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2028
Last update
Jul 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06184646
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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