MedPath

Prune Consumption and Bone Health in Young Women Using Hormonal Contraceptives

Not Applicable
Completed
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Prune groupPruneOral contraceptive users will consume 50 grams prunes daily.
Primary Outcome Measures
NameTimeMethod
Changes in bone mineral density from baseline to 12 monthsAt baseline, at 12 months

Bone density measurements with DXA

Secondary Outcome Measures
NameTimeMethod
Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 monthsAt 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

© Copyright 2025. All Rights Reserved by MedPath