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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Calcium and Vitamin D Supplements and/or Prunes on Bone Health

Conditions
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Bone Disease, Metabolic

Intervention / Treatment
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* Dietary Supplement: Prune


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control (0 g prune/day)<br>Participants only receive 500 mg calcium and 400 IU vitamin D daily for 24 months. | |
| Experimental: 30 g prune/day<br>Participants receive 500 mg calcium and 400 IU vitamin D daily for 24 months and 30 g of prune daily for 24 months. | Dietary Supplement: Prune<br>* 30 g of prune/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in bone mineral density at 12 and 24 months | bone mineral density as assessed by dual energy x-ray absorptiometry | Baseline, 12 months, and 24 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopenia, Prune, Functional food