Pilot Study on the Tolerability of Dietary Dried Plum

February 26, 2020 updated by: University of California, San Francisco
Dried plums (Prunus domestica L.) have traditionally been recognized for their health benefits related to conditions such as constipation, irregular menstrual cycles and mouth sores. This dried fruit provides high levels of fiber, vitamins and minerals. Dried plum has also been shown in animal studies to have beneficial effects on bone and can prevent the loss of bone caused by low hormone levels such as occurs after surgical removal of the ovaries. We also have shown that dried plum can prevent the loss of bone associated with aging in mice. Very few therapies for osteoporosis actually reverse bone loss and improve bone strength. The potential therapeutic value of dried plum in men and women with hormone deficiency or age-related osteoporosis is clear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

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 Francisco, California, United States, 94143
        • University of California San Francisco

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 50 yrs and 75 yrs
  • Nonsmokers
  • Normal renal and hepatic function

Exclusion Criteria:

  • Subjects who must follow a specific diet
  • Subjects on any daily medications that affect bone health
  • Subjects too heavy for the DEXA machine (weight limit 300 lbs)
  • Subjects whose BMD by DEXA indicates osteoporosis
  • Subjects unwilling to follow the diet specified
  • Pregnant women
  • Subjects who are unable to understand the consent form.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dried plum
subjects will have 25% by weight (~ 600 kcal if eat 2500 kcal diet) of their usual diet substituted by dried plum powder
Dietary supplement: dried plum powder
subjects will have 25% of their diet substituted by dried plum powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
urinary calcium excretion
Time Frame: one month
one month

Secondary Outcome Measures

Outcome Measure
Time Frame
ability to tolerate the diet
Time Frame: one month
one month

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Bernard Halloran, MD, SFVAMC

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

December 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

December 16, 2009

First Posted (Estimate)

December 18, 2009

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 26, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H592-34987-01

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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