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

January 20, 2021 updated by: Shirin Hooshmand, San Diego State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

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 Locations

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

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

50 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy men (50-79 year-old)

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.

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
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
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
Calcium and vitamin D supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone biomarkers
Time Frame: changes from baseline to 3 months
TRAP5b, BAP, CTX, P1NP
changes from baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral density
Time Frame: changes from baseline to 12 months
BMD by DXA
changes from baseline to 12 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, RD, San Diego State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 16, 2016

Primary Completion (Actual)

September 10, 2019

Study Completion (Actual)

December 15, 2019

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 20, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2521098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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