Pilot Study on the Tolerability of Dietary Dried Plum

NCT01035372 | Completed

• 1 other identifier: H592-34987-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Elderly

Keywords

healthy older people

Outcome Measures

Primary Outcomes (1)

• urinary calcium excretion

  one month

Secondary Outcomes (1)

• ability to tolerate the diet

  one month

Study Arms (1)

dried plum

EXPERIMENTAL

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

Interventions

dried plum powder DIETARY_SUPPLEMENT

subjects will have 25% of their diet substituted by dried plum powder

dried plum

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

• Deyhim F, Stoecker BJ, Brusewitz GH, Devareddy L, Arjmandi BH. Dried plum reverses bone loss in an osteopenic rat model of osteoporosis. Menopause. 2005 Nov-Dec;12(6):755-62. doi: 10.1097/01.gme.0000185486.55758.5b. Epub 2005 Nov 8.

  PMID: 16278620 BACKGROUND

Study Officials

• Bernard Halloran, MD

  SFVAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 18, 2009
• Study Start: December 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 2, 2020

Record last verified: 2020-02

Locations

US (1)