Prune Consumption and Bone Health in Young Women Using Hormonal Contraceptives

December 12, 2023 updated by: Shirin Hooshmand, San Diego State University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92182-7251
        • Shirin Hooshmand
      • San Diego, California, United States, 92182
        • School of Exercise and Nutritional Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prune group
Oral contraceptive users will consume 50 grams prunes daily.
Other: Prune
daily consumption of 50 grams prune.
No Intervention: Oral contraceptive users
Oral contraceptive users will be monitored throughout the study period.
No Intervention: Non oral contraceptive users
Non oral contraceptive users will be monitored throughout the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in bone mineral density from baseline to 12 months
Time Frame: At baseline, at 12 months
Bone density measurements with DXA
At baseline, at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months
Time Frame: At baseline, at 6 months, at 12 months
Bone biomarkers measurements with ELISA
At baseline, at 6 months, at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego State University

Investigators

  • Study Director: Shirin Hooshmand, PhD, RD, San Diego State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2019

Primary Completion (Actual)

October 30, 2023

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 59871A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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