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CompletedNCT04720833Updated Jan 22, 2021

Effect of Dried Plum on Bone and Markers of Bone Status in Men

An interventional study of dried plum and Calcium and vitamin D in Osteoporosis and Osteopenia, sponsored by San Diego State University. Completed at 1 site in United States. Open to male participants aged 50 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by San Diego State University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 3 months after the study started (first participant enrolled Sep 2016, registered Jan 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
50 Years to 79 Years
Sex
Male
01

Study summary

The principal objective of this study is to examine whether the addition of 100 g dried plum to the diets of men, regardless of their bone status, positively influences their indices of bone turnover in comparison with their corresponding baseline values and the control regimen.

Read the detailed description

To test the bone protective properties of dried plum, 66 men (50 to 79 years of age) will receive either 100 g dried plum/day or a control regimen for 12 months. Both groups will receive 500 mg calcium and 400 IU vitamin D daily.

Evaluation will be based on analyses of bone mineral density at baseline, 6 and 12-months and serum and urine markers of bone formation and resorption at baseline and 3, 6, and 12-months.

02

Conditions studied

  • Osteoporosis
  • Osteopenia

Keywords

  • Prunes
  • dried plum
  • nutrition
  • bone
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 66 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

San Diego State University is the lead sponsor of 145 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 79 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy men (50-79 year-old)

Exclusion criteria

Exclusion Criteria:

  • endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism
  • Men whose BMD t-score at any site falls below 2.5 SD of the mean will be excluded from the study and referred to their primary care physician
  • subjects treated with calcitonin, bisphosphonates, raloxifene, sodium fluoride, anabolic agents, e.g. PTH and growth hormone, or steroids for less than 3 months prior to the start of the study will be excluded.
  • body mass index (BMI) \<18 and >30 will be excluded to avoid extremes in leanness/adiposity and to readily allow body composition assessment.
  • If subjects smoke 20 cigarettes or more per day, they will be excluded.
  • Men who regularly consume dried plum or prune juice will not be accepted into the study.
05

Study design

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

Study arms

  • Experimental
    dried plum (100 g dried plum)

    Participants will receive 100 g dried plum daily plus 500 mg calcium and 300 IU vitamin D daily

    Dietary Supplement: dried plum

  • Placebo comparator
    Calcium and vitamin D

    Participants will receive 500 mg calcium and 300 IU vitamin D daily

    Dietary Supplement: Calcium and vitamin D

Interventions

  • Dietary supplementdried plum

    Dried plum

  • Dietary supplementCalcium and vitamin D

    Calcium and vitamin D supplement

06

What researchers measure

Primary outcomes

  1. Bone biomarkers

    TRAP5b, BAP, CTX, P1NP

    Time frame: changes from baseline to 3 months

Secondary outcomes

  1. Bone mineral density

    BMD by DXA

    Time frame: changes from baseline to 12 months

07

Study locations

1 site
  • School of Exercise and Nutritional Sciences
    San Diego, California 92182, United States
08

References and documents

Publications

  • Hooshmand S, Gaffen D, Eisner A, Fajardo J, Payton M, Kern M. Effects of 12 Months Consumption of 100 g Dried Plum (Prunes) on Bone Biomarkers, Density, and Strength in Men. J Med Food. 2022 Jan;25(1):40-47. doi: 10.1089/jmf.2021.0080. Epub 2021 Oct 29. PubMed 34714130 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04720833
Lead sponsor
San Diego State University
Responsible party
Shirin Hooshmand (Professor, San Diego State University) — Principal investigator
First posted
Jan 22, 2021
Start date
Sep 16, 2016
Primary completion
Sep 10, 2019
Completion
Dec 15, 2019
Last update
Jan 22, 2021

Study contacts

Shirin Hooshmand, PhD, RD
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 ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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