Effect of Dried Plum on Bone and Markers of Bone Status in Men

Study Overview
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Brief Summary
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The principal objective of this study is to examine whether the addition of 100 g dried plum to the diets of men, regardless of their bone status, positively influences their indices of bone turnover in comparison with their corresponding baseline values and the control regimen.

Detailed Description
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To test the bone protective properties of dried plum, 66 men (50 to 79 years of age) will receive either 100 g dried plum/day or a control regimen for 12 months. Both groups will receive 500 mg calcium and 400 IU vitamin D daily. Evaluation will be based on analyses of bone mineral density at baseline, 6 and 12-months and serum and urine markers of bone formation and resorption at baseline and 3, 6, and 12-months.

Official Title
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Effect of Dried Plum on Bone and Markers of Bone Status in Men

Conditions
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Osteoporosis, Osteopenia

Intervention / Treatment
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* Dietary Supplement: dried plum
* Dietary Supplement: Calcium and vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men (50-79 year-old) Exclusion Criteria: endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism Men whose BMD t-score at any site falls below 2.5 SD of the mean will be excluded from the study and referred to their primary care physician subjects treated with calcitonin, bisphosphonates, raloxifene, sodium fluoride, anabolic agents, e.g. PTH and growth hormone, or steroids for less than 3 months prior to the start of the study will be excluded. body mass index (BMI) <18 and >30 will be excluded to avoid extremes in leanness/adiposity and to readily allow body composition assessment. If subjects smoke 20 cigarettes or more per day, they will be excluded. Men who regularly consume dried plum or prune juice will not be accepted into the study.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Subjects will be randomly assign to one of the arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dried plum (100 g dried plum)<br>Participants will receive 100 g dried plum daily plus 500 mg calcium and 300 IU vitamin D daily | Dietary Supplement: dried plum<br>* Dried plum<br>|
| Placebo Comparator: Calcium and vitamin D<br>Participants will receive 500 mg calcium and 300 IU vitamin D daily | Dietary Supplement: Calcium and vitamin D<br>* Calcium and vitamin D supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone biomarkers | TRAP5b, BAP, CTX, P1NP | changes from baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density | BMD by DXA | changes from baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prunes, dried plum, nutrition, bone