Prune Consumption and Bone Health in Young Women Using Hormonal Contraceptives

Osteoporosis Risk Clinical Trial

Official title:

The Impact of Consuming California Dried Plums on Bone Health of Young Women Using Hormonal Contraceptives

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04785131
• Other study ID #: 59871A
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis Risk

Intervention

Other:
• Prune
daily consumption of 50 grams prune.

Locations

Country	Name	City	State
United States	School of Exercise and Nutritional Sciences	San Diego	California
United States	Shirin Hooshmand	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in bone mineral density from baseline to 12 months	Bone density measurements with DXA	At baseline, at 12 months
Secondary	Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months	Bone biomarkers measurements with ELISA	At baseline, at 6 months, at 12 months