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

April 18, 2024 updated by: Shirin Hooshmand, San Diego State University

Effect of Calcium and Vitamin D Supplements and/or Prunes on Bone Health

The objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92182-7251
        • Recruiting
        • San Diego State University
        • Contact:
          • Shirin Hooshmand, PhD, RD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
30 g of prune/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in bone mineral density at 12 and 24 months
Time Frame: Baseline, 12 months, and 24 months
bone mineral density as assessed by dual energy x-ray absorptiometry
Baseline, 12 months, and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months
Time Frame: Baseline, 12 months, and 24 months
bone specific alkaline phosphatase (BAP) as assessed with ELISA
Baseline, 12 months, and 24 months
Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months
Time Frame: Baseline, 12 months, and 24 months
tartrate acid phosphatase-5b (TRAP5b) as assessed with ELISA
Baseline, 12 months, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego State University

Investigators

  • Principal Investigator: Shirin Hooshmand, PhD, San Diego State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Actual)

December 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-2023-0243

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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