Prune Consumption and Bone Health in Young Women Using Hormonal Contraceptives
- Conditions
- Osteoporosis Risk
- Interventions
- Other: Prune
- Registration Number
- NCT04785131
- Lead Sponsor
- San Diego State University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
- Age 18-25
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prune group Prune Oral contraceptive users will consume 50 grams prunes daily.
- Primary Outcome Measures
Name Time Method Changes in bone mineral density from baseline to 12 months At baseline, at 12 months Bone density measurements with DXA
- Secondary Outcome Measures
Name Time Method Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months At baseline, at 6 months, at 12 months Bone biomarkers measurements with ELISA
Trial Locations
- Locations (2)
School of Exercise and Nutritional Sciences
🇺🇸San Diego, California, United States
Shirin Hooshmand
🇺🇸San Diego, California, United States