Inflammation, Polyphenols, and Genetics: A Pilot Study in Overweight and Obese Adult Males to Determine Whether Black-Raspberry Consumption Affects Markers of Inflammation in Study Participants Fed a High-Fat, High-Calorie Challenge Meal
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Serum IL-6
研究概览
简要总结
Pilot study to determine whether daily consumption of blackraspberry powder (high in polyphenols) can reduce markers of inflammation and to determine whether genetics influence baseline levels of inflammatory markers as well as individual's response to polyphenols. A total of 10 males participated in this cross-over study.
详细描述
A high-fat, high-calorie challenge meal is administered to induce an inflammatory response in overweight and obese adult males. Serum levels of CRP, TNF-alpha, and IL-6 are measured prior to the challenge meal and at various times (1,2,4,8, and 12 hours) after the challenge meal. The challenge meal is given once without intervention and once after 5 daily doses of concentrated black-raspberry powder mixed in water.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •adult males over 55 years of age
- •overweight or obese
排除标准
- •history of adverse reaction to berries or berry products
- •history of adverse reaction to high-fat, high-calorie challenge meal
- •significant liver or renal insufficiency
- •significant cognitive impairment
研究组 & 干预措施
Blackraspberry slurry, washout, water
Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days
干预措施: Blackraspberry Slurry (Dietary Supplement)
Water, washout, Blackraspberry slurry
8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days
干预措施: Blackraspberry Slurry (Dietary Supplement)
结局指标
主要结局
Serum IL-6
时间窗: acute (0-12 hours) after inflammation-causing challenge meal
Area Under the time-concentration Curve (AUC) of IL-6
次要结局
未报告次要终点
研究者
Joseph Kitzmiller
Assistant Professor
Ohio State University