Effect of Montmorency Tart Cherry Supplementation on Bone Biomarkers in Women Aged 65-80 Years: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Tartrate resistant acid phosphatase (U/L)
研究概览
简要总结
In spite of aggressive approaches to prevent and treat osteoporosis, it remains one of the most costly and debilitating diseases associated with aging. The pursuit of alternative approaches for preventing bone loss has included the investigation of a number of promising plant-based foods that can be incorporated into the diet. This project is an extension of our pre-clinical studies with tart cherry, designed to determine whether the findings from our animal study can be extended to humans. Thus, the purpose of this project is to investigate the dose-dependent effect of tart cherry juice consumption on biomarkers of bone metabolism in women, aged 65-80 years. The hypothesis to be tested is that three months of tart cherry supplementation will improve bone biomarkers in a dose-dependent manner. Moreover, these improvements in bone metabolism will correspond to a decrease in markers of inflammation and oxidative stress.
详细描述
Tart cherries are an excellent course of phenolic compounds and anthocyanins, and in pre-clinical studies have been shown to prevent age-related bone loss. Based on these findings, this pilot study was designed to investigate the effects of three months of tart cherry juice supplementation on improving markers of oxidative stress and bone metabolism in older women. Women (n=30), aged 65-80 yrs, will be recruited for the study and randomly assigned to one of two doses of tart cherry juice (8 or 16 fl oz) per day prepared from a Montmorency cherry concentrate (King Orchards, Central Lake, MI). Study participants will complete two study visits to the Nutritional Sciences Clinical Research Center. At the first visit, informed consent will be obtained and relevant medical history and anthropometric measures will be taken by the research team. A blood draw will be performed to assess baseline, biochemical markers of bone metabolism and inflammation as well as indicators of oxidative status. A physical activity and food frequency questionnaire will be completed by each study participant. Whole body, hip and spine bone density (DXA) scan will be performed by certified bone densitometrist. A 3-month final visit will be scheduled for all study participants in which most of the procedures described at baseline (except DXA) will be repeated. Change in primary and secondary outcome measures (i.e., bone, inflammation and oxidative stress biomarkers) will be assessed.
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
- 65 Years 至 80 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women, 65-80 years of age
- •Capacity to give informed consent
排除标准
- •Hormone replacement therapy in the 3 months prior to starting the study
- •Bisphosphonates in the 3 months prior to starting the study
- •Raloxifene in the 3 months prior to starting the study
- •Intermittent parathyroid hormone in the 3 months prior to starting the study
- •Growth hormone or steroids in the 3 months prior to starting the study
- •Osteoporosis
- •Renal disease
- •Cardiovascular disease
- •Respiratory disease
- •Gastrointestinal diseases
- •Liver disease
- •Other chronic conditions that could affect bone metabolism
结局指标
主要结局
Tartrate resistant acid phosphatase (U/L)
时间窗: Change from baseline to final visits (3 month intervention)
Bone resorption marker
Bone-specific alkaline phosphatase (U/L)
时间窗: Change from baseline to final visits (3 month intervention)
Bone formation marker
次要结局
- Thiobarbituric acid reactive species (TBARS) (U/L)(Change from baseline to final visits (3 month intervention))
- C-reactive protein (mg/L)(Change from baseline to final visits (3 month intervention))
研究者
Brenda Smith
Professor of Nutrition
Oklahoma State University