Status:
COMPLETED
Dried Plums Prevent Inflammation And Improve Bone Health in Osteopenic Men
Lead Sponsor:
Florida State University
Conditions:
Osteoporosis, Osteopenia
Eligibility:
MALE
50-80 years
Phase:
NA
Brief Summary
The goals of this study are 1) to investigate the extent to which dried plum improves bone health by measuring bone density (a measure of bone strength) of whole body, hip, and forearm, indicators of ...
Detailed Description
Osteoporosis in men is an important yet an understudied debilitating disease. To date, most therapies are directed towards postmenopausal osteoporosis, and the efficacy of these therapies is not estab...
Eligibility Criteria
Inclusion
- Healthy men, between the ages of 55 and 80, whose lumbar spine BMD t-score is between 0.1 and 2.5 SD below the mean will be included. Participants who are not on testosterone and/or other pharmacological agents known to affect bone, or who have initiated an exercise program within the past 12 months known to influence bone (e.g. resistance training exercise), will be enrolled in this proposed study.
Exclusion
- The subjects who will be recruited for the study should not be receiving endocrine (e.g. prednisone, other glucocorticoids) or neuroactive (e.g. dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism. Men who have initiated regular exercise regimens known to influence bone within the past 12 months prior to the study, e.g. resistance exercise training will also be excluded. Men whose BMD t-score at any site that falls below 2.5 SD of the mean will be excluded from the study. Furthermore, subjects treated with calcitonin, bisphosphonates, denosumab, raloxifene, anabolic agents, e.g. PTH and growth hormone, or steroids within a year prior to the start of the study will be excluded. In addition, subjects with metabolic bone disease, renal disease, cancer, cardiovascular disease, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease, or other chronic diseases will be excluded. Potential subjects with a body mass index (BMI) \< 18 and \> 40 will be excluded to avoid extremes in leanness/adiposity and to readily allow body composition assessment. If subjects smoke ≥ 20 cigarettes per day, they will be excluded. Also men who regularly consume dried plum or prune juice will not be accepted into the study.
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03408119
Start Date
November 20 2017
End Date
August 30 2022
Last Update
October 7 2022
Active Locations (1)
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1
Florida State University
Tallahassee, Florida, United States, 32306