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Prunes for Bone Health in Contraceptive Users

N/A
Waitlist Available
Research Sponsored by San Diego State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-25
Be between 18 and 65 years old
Must not have
Diabetes mellitus
Metabolic bone disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, at 6 months, at 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether dried plum can help prevent bone loss in young adults who use oral contraceptives.

Who is the study for?
This trial is for young women aged 18-25 who use hormonal contraceptives. It's not suitable for those with chronic diseases like diabetes, liver or kidney issues, heavy smokers, or anyone on medication that affects bone and calcium metabolism.
What is being tested?
The study aims to see if eating 50 grams of dried plums every day for a year can help prevent bone loss or increase bone growth in young adult women using oral contraceptives.
What are the potential side effects?
While the trial focuses on prunes which are generally safe, potential side effects may include digestive changes such as bloating, gas, and bowel movement alterations due to their fiber content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 25 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes.
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I have a metabolic bone disease.
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I have cardiovascular disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, at 6 months, at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, at 6 months, at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in bone mineral density from baseline to 12 months
Secondary study objectives
Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Prune groupExperimental Treatment1 Intervention
Oral contraceptive users will consume 50 grams prunes daily.
Group II: Oral contraceptive usersActive Control1 Intervention
Oral contraceptive users will be monitored throughout the study period.
Group III: Non oral contraceptive usersActive Control1 Intervention
Non oral contraceptive users will be monitored throughout the study period.

Find a Location

Who is running the clinical trial?

San Diego State UniversityLead Sponsor
169 Previous Clinical Trials
114,784 Total Patients Enrolled
Shirin Hooshmand, PhD, RDStudy Director - San Diego State University
San Diego State University
3 Previous Clinical Trials
154 Total Patients Enrolled

Media Library

Prune (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04785131 — N/A
Bone Loss Research Study Groups: Prune group, Oral contraceptive users, Non oral contraceptive users
Bone Loss Clinical Trial 2023: Prune Highlights & Side Effects. Trial Name: NCT04785131 — N/A
Prune (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04785131 — N/A
~15 spots leftby Nov 2025
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