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Dried Plums for Bone Health in Older Postmenopausal Women

Primary Purpose

Bone Diseases, Metabolic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dried Plum
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bone Diseases, Metabolic focused on measuring Osteoporosis, Dried plum, functional food

Eligibility Criteria

65 Years - 79 Years (Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control (0 g Dried plum/day)

    50 g Dried plum/day

    100 g Dried plum/day

    Arm Description

    Participants only received 400IU of vitamin D and 500mg of calcium daily for 6 months.

    Participants received 400IU of vitamin D and 500mg of calcium and 50g of dried plum daily for 6 months.

    Participants received 400IU of vitamin D and 500mg of calcium and 100g of dried plum daily for 6 months.

    Outcomes

    Primary Outcome Measures

    Bone Mineral Density

    Secondary Outcome Measures

    Changes from baseline in bone specific alkaline phosphatase at 3 months and 6 months

    Full Information

    First Posted
    December 11, 2014
    Last Updated
    December 24, 2014
    Sponsor
    San Diego State University
    Collaborators
    Florida State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02325895
    Brief Title
    Dried Plums for Bone Health in Older Postmenopausal Women
    Official Title
    Effect of Dried Plum on Bone and Bone Biomarkers in Older Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    April 2014 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    San Diego State University
    Collaborators
    Florida State University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Diseases, Metabolic
    Keywords
    Osteoporosis, Dried plum, functional food

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control (0 g Dried plum/day)
    Arm Type
    No Intervention
    Arm Description
    Participants only received 400IU of vitamin D and 500mg of calcium daily for 6 months.
    Arm Title
    50 g Dried plum/day
    Arm Type
    Experimental
    Arm Description
    Participants received 400IU of vitamin D and 500mg of calcium and 50g of dried plum daily for 6 months.
    Arm Title
    100 g Dried plum/day
    Arm Type
    Experimental
    Arm Description
    Participants received 400IU of vitamin D and 500mg of calcium and 100g of dried plum daily for 6 months.
    Intervention Type
    Other
    Intervention Name(s)
    Dried Plum
    Intervention Description
    Three doses of dried plum (0 g, 50 g and 100g) were used as intervention.
    Primary Outcome Measure Information:
    Title
    Bone Mineral Density
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Changes from baseline in bone specific alkaline phosphatase at 3 months and 6 months
    Time Frame
    baseline, 3 months and 6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shirin Hooshmand, PhD
    Organizational Affiliation
    San Diego State Univeristy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26902092
    Citation
    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.
    Results Reference
    derived

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    Dried Plums for Bone Health in Older Postmenopausal Women

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