Effect of Dried Plum on Bone and Markers of Bone Status in Men
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: dried plum (100 g dried plum) Participants will receive 100 g dried plum daily plus 500 mg calcium and 300 IU vitamin D daily |
Dietary Supplement: dried plum
Dried plum
|
Placebo Comparator: Calcium and vitamin D Participants will receive 500 mg calcium and 300 IU vitamin D daily |
Dietary Supplement: Calcium and vitamin D
Calcium and vitamin D supplement
|
Outcome Measures
Primary Outcome Measures
- Bone biomarkers [changes from baseline to 3 months]
TRAP5b, BAP, CTX, P1NP
Secondary Outcome Measures
- Bone mineral density [changes from baseline to 12 months]
BMD by DXA
Eligibility Criteria
Criteria
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
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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.
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body mass index (BMI) <18 and >30 will be excluded to avoid extremes in leanness/adiposity and to readily allow body composition assessment.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | School of Exercise and Nutritional Sciences | San Diego | California | United States | 92182 |
Sponsors and Collaborators
- San Diego State University
Investigators
- Principal Investigator: Shirin Hooshmand, PhD, RD, San Diego State University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2521098