NCT04785131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 8, 2025

Status Verified

December 1, 2024

Enrollment Period

3.9 years

First QC Date

March 3, 2021

Last Update Submit

January 6, 2025

Conditions

Osteoporosis Risk

Keywords

PruneBone healthOral contraceptivesWomen health

Outcome Measures

Primary Outcomes (1)

  • Changes in bone mineral density from baseline to 12 months

    Bone density measurements with DXA

    At baseline, at 12 months

Secondary Outcomes (1)

  • Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months

    At baseline, at 6 months, at 12 months

Study Arms (3)

Prune group

EXPERIMENTAL

Oral contraceptive users will consume 50 grams prunes daily.

Other: Prune

Oral contraceptive users

NO INTERVENTION

Oral contraceptive users will be monitored throughout the study period.

Non oral contraceptive users

NO INTERVENTION

Non oral contraceptive users will be monitored throughout the study period.

Interventions

PruneOTHER

daily consumption of 50 grams prune.

Prune group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-25

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shirin Hooshmand

San Diego, California, 92182-7251, United States

Location

School of Exercise and Nutritional Sciences

San Diego, California, 92182, United States

Location

Related Publications (1)

  • DeMasi T, Tsang M, Mueller J, Giltvedt K, Nguyen TN, Kern M, Hooshmand S. Prunes May Blunt Adverse Effects of Oral Contraceptives on Bone Health in Young Adult Women: A Randomized Clinical Trial. Curr Dev Nutr. 2024 Jul 18;8(9):104417. doi: 10.1016/j.cdnut.2024.104417. eCollection 2024 Sep.

    PMID: 39310666DERIVED

Study Officials

  • Shirin Hooshmand, PhD, RD

    San Diego State University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 5, 2021

Study Start

November 30, 2019

Primary Completion

October 30, 2023

Study Completion

December 30, 2024

Last Updated

January 8, 2025

Record last verified: 2024-12

Locations

US(2)