Recruiting

Prunes

Sponsor:

San Diego State University

Code:

NCT06184646

Conditions

Bone Disease, Metabolic

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Prune

Study Details

Brief 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.

Conditions

Bone Disease, Metabolic

Study ID

NCT06184646

Start date

Mar 15, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Prune

30 g of prune/day

Primary outcome measure

  • Changes from baseline in bone mineral density at 12 and 24 months [ Time Frame: Baseline, 12 months, and 24 months ]

Central Contacts and Locations

Central contacts

Shirin Hooshmand, PhD

619-594-6823shooshmand@sdsu.edu

Locations

San Diego State University

Recruiting

San Diego, California, United States, 92182-7251

More Information

Sponsor

San Diego State University

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Osteopenia
  • Prune
  • Functional food

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by San Diego State University on 2026-07-01.