Examining the effects of prunes on bone health in postmenopausal women
Effect of Calcium and Vitamin D Supplements and/or Prunes on Bone Health
This study tests if eating 30 grams of prunes every day can help prevent bone loss in postmenopausal women who are also taking calcium and vitamin D supplements.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Sex | Female |
| Sponsor | San Diego State University Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06184646 on ClinicalTrials.gov |
What this trial studies
This study investigates whether the consumption of 30 grams of prunes daily, alongside calcium and vitamin D supplements, can help prevent bone loss in postmenopausal women. Two hundred participants will be randomly assigned to either the prune group or a control group with no prunes, while both groups receive the same calcium and vitamin D supplementation. Blood samples will be collected at baseline, 12, and 24 months to measure biomarkers related to bone turnover, and bone mineral density will be assessed using DXA and pQCT scans at the same intervals. Additionally, participants will provide information on their physical activity and dietary habits to control for potential confounding factors.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women with a bone mineral density t-score between 0.5 and 2 SD below the mean who are not on hormone replacement therapy or other medications affecting bone health.
Not a fit: Patients with a bone mineral density t-score below 2.5 SD, those on certain medications affecting bone metabolism, smokers, and regular consumers of prunes or prune juice may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural dietary intervention to help improve bone health in postmenopausal women.
How similar studies have performed: While the specific use of prunes for bone health is novel, other studies have shown positive effects of dietary interventions on bone health, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Postmenopausal * BMD t-score is between 0.5 and 2 SD below the mean * Not on hormone replacement therapy (HRT) and/or other pharmacological agents known to affect bone for at least three months prior to initiation of the study Exclusion Criteria: * Women whose BMD t-score at any site falls below 2.5 SD of the mean * Subjects receiving endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism * Subjects who smoke cigarettes or vape * Regular consumption of dried plum or prune juice
Where this trial is running
San Diego, California
- San Diego State University — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Shirin Hooshmand, PhD — San Diego State University
- Study coordinator: Shirin Hooshmand, PhD
- Email: shooshmand@sdsu.edu
- Phone: 619-594-6823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.