Osteoporosis, Osteopenia
Conditions
Keywords
Prunes, dried plum, nutrition, bone
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.
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.
Interventions
DIETARY_SUPPLEMENTdried plum
Dried plum
DIETARY_SUPPLEMENTCalcium and vitamin D
Calcium and vitamin D supplement
Sponsors
San Diego State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Subjects will be randomly assign to one of the arms.
Eligibility
Sex/Gender
MALE
Age
50 Years to 79 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone biomarkers | changes from baseline to 3 months | TRAP5b, BAP, CTX, P1NP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density | changes from baseline to 12 months | BMD by DXA |
Countries
United States
Outcome results
None listed