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Pilot Study on the Tolerability of Dietary Dried Plum

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01035372
First received: December 16, 2009
Last updated: April 12, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Healthy
Elderly
 Dietary Supplement: dried plum powder

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pilot Study on the Tolerability of Dietary Dried Plum

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • urinary calcium excretion [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ability to tolerate the diet [ Time Frame: one month ] [ Designated as safety issue: No ]

Estimated Enrollment: 6
Study Start Date: December 2009
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035372

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Bernard Halloran, MD SFVAMC
  More Information

Publications:

Responsible Party: Bernard Halloran, SFVAMC
ClinicalTrials.gov Identifier: NCT01035372     History of Changes
Other Study ID Numbers: H592-34987-01
Study First Received: December 16, 2009
Last Updated: April 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
healthy older people

ClinicalTrials.gov processed this record on May 19, 2013