Dried Plums Prevent Inflammation And Improve Bone Health in Osteopenic Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Bone mineral density (spine)
研究概览
简要总结
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 bone formation and bone breakdown, and 2) to determine the anti-inflammatory effects of dried plum by assessing biomarkers of inflammation. Additionally, relevant medical history and lifestyle variables will be recorded.
详细描述
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 established for male osteoporosis. Therefore, due to concerns regarding the increasing prevalence of male osteoporosis and minimal treatment options available, it is imperative to further investigate the role of readily available preventative therapies such as functional foods on improving bone health in men.
In general, consumption of fruits and vegetables has health-protective effects, in part, through the prevention of inflammation and its related conditions, including bone loss. These protective effects have been primarily attributed to their bioactive components, including polyphenols. Dried plums (Prunus domestica L.) have been ranked as having one of the highest oxygen radical absorbance capacities among the commonly consumed fruits and vegetables, likely due to the fact that they are a rich source of polyphenolic compounds, including chlorogenic acid and neochlorogenic acid, which are potent antioxidants. For these reasons, dried plums have been investigated to determine if they would have beneficial effects on bone health, and their bone-protective effects have been well-established in animal models and to some degree in humans by our laboratory as well as others.
The long-term goal of this proposed research is to develop new approaches to prevent chronic inflammation and subsequently to prevent and/or reverse bone loss in osteopenic men, thereby reducing the risk of osteoporotic fractures. The rationale for conducting this study is to test the extent to which dried plum prevents inflammation and improves bone health in osteopenic men. Based on the promising findings of our previous research studies and those of others, we hypothesize that chronic consumption of dried plum will prevent inflammation thereby preventing and/or reversing further bone loss at the lumbar spine in osteopenic men. Healthy men between the ages of 55 and 80 years old with a baseline lumbar spine bone mineral density (BMD) t-score between 1 and 2 standard deviations (SD) below the mean, characterizing mild to moderate bone loss, will be recruited. The study participants must not have been on drug therapy for osteoporosis and must not have begun a new exercise regimen known to affect bone metabolism for at least six months prior to the start of the study. Evaluation will be based on quantitative assessments of serum and urinary markers of bone formation and bone resorption and bone density measurements. Nutrition indices that are known to influence skeletal mass such as dietary intakes of calcium, protein, fiber, and magnesium will also be assessed as well as relevant medical history and lifestyle variables.
The rationale for selecting osteopenic men rather than those with normal bone is to test our hypothesis that dried plum reverses bone loss similar to male rats. However, no further loss of BMD should also be considered a positive finding. Men with a t-score < -2 SD will be excluded because they are close to being osteoporotic. Changes in BMD and bone mineral content (BMC) of the lumbar spine are the primary outcome variables. Secondary outcome variables are the changes in BMD and BMC of whole body, hip, and forearm; and biomarkers of inflammation and bone turnover. The rationale for choosing the lumbar spine as our primary outcome variable site, is due to the high rates of bone loss that typically occur first in the lumbar spine and other areas of high trabecular bone content where there are many metabolically active surfaces. To test our hypothesis, two specific aims are proposed as follows:
Aim 1: To investigate the extent to which dried plum improves bone health by measuring:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Bone mineral density (spine)
时间窗: 1 year
BMD of the lumbar (L1-L4) vertebrae
次要结局
- Bone mineral content (spine)(1 year)
- Bone mineral Density (other)(1 year)
- Bone Mineral Content (other)(1 year)
研究者
Bahram Arjmandi
Dr. Bahram H. Arjmandi, PhD, RD
Florida State University
