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

Not Applicable

Recruiting

• Conditions: Bone Disease, Metabolic
• Interventions: Dietary Supplement: Prune

• Registration Number: NCT06184646
• Lead Sponsor: San Diego State University

Brief Summary

The objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women.

Detailed Description

Two hundred randomly assigned to one of two treatment groups: 1) 30 g prunes and 2) control (0 g prunes). Both groups received 500 mg calcium and 400 IU Vitamin D as a daily supplement. Blood samples are collected at baseline, 12 and 24 months to assess biomarkers of bone turnover. Physical activity recall and food records are obtained at baseline, 12 and 24 months to examine physical activity and dietary confounders as potential covariates. Dual-energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) will be completed at baseline, 12 and 24 months to examine bone mineral density and structure.

Study Timeline

• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-28
• Study Start: 2024-03-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-22
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30 g prune/day	Prune	Participants receive 500 mg calcium and 400 IU vitamin D daily for 24 months and 30 g of prune daily for 24 months.

Primary Outcome Measures

Name	Time	Method
Changes from baseline in bone mineral density at 12 and 24 months	Baseline, 12 months, and 24 months	bone mineral density as assessed by dual energy x-ray absorptiometry

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months	Baseline, 12 months, and 24 months	bone specific alkaline phosphatase (BAP) as assessed with ELISA
Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months	Baseline, 12 months, and 24 months	tartrate acid phosphatase-5b (TRAP5b) as assessed with ELISA

Trial Locations

Locations (1)

San Diego State University; 🇺🇸 San Diego, California, United States