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Dried Plums for Bone Health in Older Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT02325895
Recruitment Status : Completed
First Posted : December 25, 2014
Last Update Posted : December 25, 2014
Sponsor:
Collaborator:
Florida State University
Information provided by (Responsible Party):
Dr. Shirin Hooshmand, San Diego State University

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.

Condition or disease Intervention/treatment Phase
Bone Diseases, Metabolic Other: Dried Plum Not Applicable

Detailed Description:
Forty-five randomly assigned into one of three treatment groups: 1) 50g dried plum; 2) 100g dried plum; and 3) control (0g dried plum). All groups received 500mg calcium and 400 IU vitamin D as a daily supplement. Blood samples were collected at baseline, 3 and 6 months to assess biomarkers of bone turnover. Physical activity recall and 3-day food records were obtained at baseline, 3 and 6 months to examine physical activity and dietary confounders as potential covariates

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Dried Plum on Bone and Bone Biomarkers in Older Women
Study Start Date : August 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
No Intervention: Control (0 g Dried plum/day)
Participants only received 400IU of vitamin D and 500mg of calcium daily for 6 months.
Experimental: 50 g Dried plum/day
Participants received 400IU of vitamin D and 500mg of calcium and 50g of dried plum daily for 6 months.
Other: Dried Plum
Three doses of dried plum (0 g, 50 g and 100g) were used as intervention.

Experimental: 100 g Dried plum/day
Participants received 400IU of vitamin D and 500mg of calcium and 100g of dried plum daily for 6 months.
Other: Dried Plum
Three doses of dried plum (0 g, 50 g and 100g) were used as intervention.




Primary Outcome Measures :
  1. Bone Mineral Density [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Changes from baseline in bone specific alkaline phosphatase at 3 months and 6 months [ Time Frame: baseline, 3 months and 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 79 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMD t-score of L1-L4 between -1 to -2.5 standard deviation of the mean
  • Age 65 to 79

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325895


Sponsors and Collaborators
San Diego State University
Florida State University
Investigators
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Principal Investigator: Shirin Hooshmand, PhD San Diego State Univeristy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Shirin Hooshmand, Assistant Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT02325895    
Other Study ID Numbers: 57114A
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: December 25, 2014
Last Verified: December 2014
Keywords provided by Dr. Shirin Hooshmand, San Diego State University:
Osteoporosis
Dried plum
functional food
Additional relevant MeSH terms:
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Bone Diseases
Bone Diseases, Metabolic
Metabolic Diseases
Musculoskeletal Diseases