Effect of Dried Plum on Bone and Markers of Bone Status in Men
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- San Diego State University
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Bone biomarkers
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 79 Years (Adult, Older Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
dried plum (100 g dried plum)
Participants will receive 100 g dried plum daily plus 500 mg calcium and 300 IU vitamin D daily
Intervention: dried plum (Dietary Supplement)
Calcium and vitamin D
Participants will receive 500 mg calcium and 300 IU vitamin D daily
Intervention: Calcium and vitamin D (Dietary Supplement)
Outcomes
Primary Outcomes
Bone biomarkers
Time Frame: changes from baseline to 3 months
TRAP5b, BAP, CTX, P1NP
Secondary Outcomes
- Bone mineral density(changes from baseline to 12 months)
Investigators
Shirin Hooshmand
Professor
San Diego State University