Pilot Study on the Tolerability of Dietary Dried Plum

NCT ID: NCT01035372

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

dried plum

subjects will have 25% by weight (\~ 600 kcal if eat 2500 kcal diet) of their usual diet substituted by dried plum powder

Group Type: EXPERIMENTAL

dried plum powder

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

dried plum powder

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernard Halloran, MD

Role: PRINCIPAL_INVESTIGATOR

SFVAMC

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16278620 (View on PubMed)

Other Identifiers

H592-34987-01

Identifier Type: -

Identifier Source: org_study_id