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30 g prune/day for Metabolic Bone Diseases

N/A

Recruiting

Led By Shirin Hooshmand, PhD

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

Postmenopausal

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 months, and 24 months

Awards & highlights

Study Summary

"This trial aims to see if taking calcium and vitamin D supplements and/or eating prunes can help stop bone loss in women after menopause."

Who is the study for?

This trial is for postmenopausal women who have a bone mineral density (BMD) t-score between -0.5 and -2, indicating some loss of bone density but not severe osteoporosis. Participants should not be on hormone replacement therapy or other drugs affecting bone health for at least three months before the study starts.Check my eligibility

What is being tested?

The study is testing whether prunes, in combination with calcium and vitamin D supplements, can help prevent further bone loss in postmenopausal women compared to just taking the supplements alone.See study design

What are the potential side effects?

Prunes are generally safe but may cause digestive issues like bloating or gas due to their high fiber content. Overconsumption might lead to diarrhea or an upset stomach.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am postmenopausal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 months, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 months, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes from baseline in bone mineral density at 12 and 24 months

Secondary outcome measures

Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months

Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 30 g prune/dayExperimental Treatment1 Intervention

Participants receive 500 mg calcium and 400 IU vitamin D daily for 24 months and 30 g of prune daily for 24 months.

Group II: Control (0 g prune/day)Active Control1 Intervention

Participants only receive 500 mg calcium and 400 IU vitamin D daily for 24 months.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

San Diego State UniversityLead Sponsor

154 Previous Clinical Trials

115,928 Total Patients Enrolled

Shirin Hooshmand, PhDPrincipal InvestigatorSan Diego State University

3 Previous Clinical Trials

115 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals who have been granted admission to participate in this clinical study?

"Indeed, the details on clinicaltrials.gov specify that this research is actively seeking participants. The trial was first published on March 15th, 2024, and last revised on April 18th, 2024. A total of 200 individuals are sought from a single site for enrollment in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Elucidating the Minimal Effective Dose of Prunes for Bone Health in Postmenopausal Women

Shirin Hooshmand 2024. "Elucidating the Minimal Effective Dose of Prunes for Bone Health in Postmenopausal Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06184646.

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