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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, at 6 months, at 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 25 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, at 6 months, at 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, at 6 months, at 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in bone mineral density from baseline to 12 months
Secondary outcome measures
Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months
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
151 Previous Clinical Trials
86,231 Total Patients Enrolled
2 Trials studying Osteoporosis
221 Patients Enrolled for Osteoporosis
Shirin Hooshmand, PhD, RDStudy Director - San Diego State University
San Diego State University
3 Previous Clinical Trials
154 Total Patients Enrolled
1 Trials studying Osteoporosis
66 Patients Enrolled for Osteoporosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes.I have been diagnosed with cancer.I have a gastrointestinal condition.I smoke more than 20 cigarettes a day and take medication that affects bone and calcium in my body.I have a chronic condition or liver disease.You often eat dried plums or drink prune juice.I am between 18 and 25 years old.I have a lung or breathing condition.I have a metabolic bone disease.I have kidney disease.I have cardiovascular disease.
Research Study Groups:
This trial has the following groups:- Group 1: Prune group
- Group 2: Oral contraceptive users
- Group 3: Non oral contraceptive users
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can I contribute to this research endeavor?
"This osteoporosis trial is available to 90 young adults aged between 18 and 25. The primary prerequisites for potential participants are that they fall within the aforementioned age bracket."
Answered by AI
To what extent is patient participation in this experiment limited?
"Affirmative. According to the information made available on clinicaltrials.gov, this research trial is currently seeking participants for enrollment. This experiment was first published on November 30th 2019 and has seen its last update occur in March 3rd 2021; 90 enrollees are being sought from a single location."
Answered by AI
Are participants aged 55 and above eligible to join this experiment?
"The lower and upper age limits for the participants in this clinical trial are 18 and 25 years old, respectively."
Answered by AI
Does this research endeavor presently accept new participants?
"Affirmative. According to clinicaltrials.gov, this research endeavor is currently enrolling participants; the trial was launched on November 30th 2019 and its most recent update occurred on March 3rd 2021. Approximately 90 individuals are required across 1 centre of care."
Answered by AI
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