Osteoporosis Risk
Conditions
Keywords
Prune, Bone health, Oral contraceptives, Women health
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.
Interventions
OTHERPrune
daily consumption of 50 grams prune.
Sponsors
San Diego State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in bone mineral density from baseline to 12 months | At baseline, at 12 months | Bone density measurements with DXA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed