Back to resultsPrune Consumption and Bone Health in Young Women Using Hormonal Contraceptives
Primary Purpose
Osteoporosis Risk
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prune
Sponsored by
About this trial
This is an interventional other trial for Osteoporosis Risk focused on measuring Prune, Bone health, Oral contraceptives, Women health
Eligibility Criteria
Inclusion Criteria:
- Age 18-25
Exclusion Criteria:
- 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
Sites / Locations
- Shirin HooshmandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Prune group
Oral contraceptive users
Non oral contraceptive users
Arm Description
Oral contraceptive users will consume 50 grams prunes daily.
Oral contraceptive users will be monitored throughout the study period.
Non oral contraceptive users will be monitored throughout the study period.
Outcomes
Primary Outcome Measures
Changes in bone mineral density from baseline to 12 months
Secondary Outcome Measures
Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months
Full Information
NCT ID
NCT04785131
First Posted
March 3, 2021
Last Updated
March 3, 2021
Sponsor
San Diego State University
1. Study Identification
Unique Protocol Identification Number
NCT04785131
Brief Title
Prune Consumption and Bone Health in Young Women Using Hormonal Contraceptives
Official Title
The Impact of Consuming California Dried Plums on Bone Health of Young Women Using Hormonal Contraceptives
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to determine if 12 months of consuming 50 grams of dried plum daily will prevent bone loss or augment bone accrual of young adult oral contraceptive (OC) users.
Detailed Description
Eligible participants will be assigned among three groups 1) control non-OC users, 2) control OC users, and 3) dried plum OC users. OC users will be randomly allocated to the dried plum OC group, which will consume 50 g dried plum daily for 12 months, or a control group, for which dried plums will not be allowed and no control food will be provided.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis Risk
Keywords
Prune, Bone health, Oral contraceptives, Women health
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prune group
Arm Type
Experimental
Arm Description
Oral contraceptive users will consume 50 grams prunes daily.
Arm Title
Oral contraceptive users
Arm Type
No Intervention
Arm Description
Oral contraceptive users will be monitored throughout the study period.
Arm Title
Non oral contraceptive users
Arm Type
No Intervention
Arm Description
Non oral contraceptive users will be monitored throughout the study period.
Intervention Type
Other
Intervention Name(s)
Prune
Intervention Description
daily consumption of 50 grams prune.
Primary Outcome Measure Information:
Title
Changes in bone mineral density from baseline to 12 months
Time Frame
At baseline, at 12 months
Secondary Outcome Measure Information:
Title
Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months
Time Frame
At baseline, at 6 months, at 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-25
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shirin Hooshmand, PhD, RD
Phone
6195946984
Email
shooshmand@sdsu.edu
Facility Information:
Facility Name
Shirin Hooshmand
City
San Diego
State/Province
California
ZIP/Postal Code
92182-7251
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirin Hooshmand, PhD, RD
Phone
619-594-6984
Email
shooshmand@sdsu.edu
12. IPD Sharing Statement
Learn more about this trial
Prune Consumption and Bone Health in Young Women Using Hormonal Contraceptives
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