Osteoporosis Clinical Trial
Official title:
Effect of Dried Plum on Bone and Markers of Bone Status in Men
Verified date | January 2021 |
Source | San Diego State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | December 15, 2019 |
Est. primary completion date | September 10, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 50 Years to 79 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | School of Exercise and Nutritional Sciences | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
San Diego State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone biomarkers | TRAP5b, BAP, CTX, P1NP | changes from baseline to 3 months | |
Secondary | Bone mineral density | BMD by DXA | changes from baseline to 12 months |
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