Dried Plums for Bone Health in Older Postmenopausal Women
Effect of Dried Plum on Bone and Bone Biomarkers in Older Women
1 other identifier
interventional
48
0 countries
N/A
Brief Summary
The objective of the investigators current study was to examine whether 50 g dried plum would be as effective as 100 g dried plum in reversing bone loss in osteopenic older postmenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 11, 2014
CompletedFirst Posted
Study publicly available on registry
December 25, 2014
CompletedDecember 25, 2014
December 1, 2014
1.7 years
December 11, 2014
December 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone Mineral Density
6 months
Secondary Outcomes (1)
Changes from baseline in bone specific alkaline phosphatase at 3 months and 6 months
baseline, 3 months and 6 months
Study Arms (3)
Control (0 g Dried plum/day)
NO INTERVENTIONParticipants only received 400IU of vitamin D and 500mg of calcium daily for 6 months.
50 g Dried plum/day
EXPERIMENTALParticipants received 400IU of vitamin D and 500mg of calcium and 50g of dried plum daily for 6 months.
100 g Dried plum/day
EXPERIMENTALParticipants received 400IU of vitamin D and 500mg of calcium and 100g of dried plum daily for 6 months.
Interventions
Three doses of dried plum (0 g, 50 g and 100g) were used as intervention.
Eligibility Criteria
You may qualify if:
- BMD t-score of L1-L4 between -1 to -2.5 standard deviation of the mean
- Age 65 to 79
You may not qualify if:
- BMD t-score at any site fell below 2.5 standard deviation of the mean
- Subjects treated with calcitonin, bisphosphonates, raloxifene and/or anabolic agents such as parathyroid hormone and growth hormone, or steroids within three months before the start of the study
- Metabolic bone disease, renal disease, cancer, CVD, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease or other chronic diseases, heavy smoking (more than twenty cigarettes/day) and current use of any prescription medications known to alter bone and calcium metabolism
- Regularly consumed dried plum or prune juice were not included in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- San Diego State Universitylead
- Florida State Universitycollaborator
Related Publications (1)
Hooshmand S, Kern M, Metti D, Shamloufard P, Chai SC, Johnson SA, Payton ME, Arjmandi BH. The effect of two doses of dried plum on bone density and bone biomarkers in osteopenic postmenopausal women: a randomized, controlled trial. Osteoporos Int. 2016 Jul;27(7):2271-2279. doi: 10.1007/s00198-016-3524-8. Epub 2016 Feb 22.
PMID: 26902092DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shirin Hooshmand, PhD
San Diego State Univeristy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 11, 2014
First Posted
December 25, 2014
Study Start
August 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
December 25, 2014
Record last verified: 2014-12