Effect of Tart Cherry Juice on Inflammation and Dyslipidemia in Overweight and Obese Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- TCJ and hsCRP
研究概览
简要总结
In this study, the investigators recruited at-risk individuals (n=10) who were overweight (25.0-29.9 kg/m2) and obese (> 30.0 kg/m2) and likely to exhibit one or more conditions associated with Metabolic Syndrome (MetS). In this 10-week placebo-controlled 2 x 2 crossover dietary intervention, the investigators randomized participants (n=10) to consume 240 mL (8 ounces) daily of either placebo (artificial cherry-flavored, anthocyanin-free beverage) or authentic TCJ for 4 weeks, followed by a 2-week washout period, then consumption of the alternate beverage for 4 weeks. In this study, the investigators determined the effect of TCJ in at-risk participants on markers of inflammation, glycemia, and lipidemia.
详细描述
In this study, the investigators recruited at-risk individuals (n=10) who were overweight (25.0-29.9 kg/m2) and obese (> 30.0 kg/m2) and likely to exhibit one or more conditions associated with MetS. Participants were >18 years of age, not pregnant, not diabetic, with no unresolved infections or diseases (diabetes, CVD, IBD, cancer and liver disease), and nonsmokers. Histories of medication and dietary supplement use were collected and those taking anti-inflammatory or lipid-lowering medications were excluded. After enrollment, subjects were randomly assigned to consume daily either 240 mL (8 ounces) of authentic TCJ (R.W. Knudsen, Chico, CA) or a placebo beverage (commercial fruit punch; Great Value, Bentonville, AR) for 4 weeks. After a 2-week washout period, participants consumed the alternate beverage for 4 weeks in this 10-week 2x2 crossover, placebo-controlled dietary intervention. Subsequently, the investigators determined the effect of TCJ in at-risk participants on markers of lipidemia (HDL, LDL, triglycerides, VLDL, total cholesterol), glycemia (fasting insulin and glucose, HOMA, QUICKI, McAuley indirect indices), and inflammation (hsCRP, TNF-alpha, and ESR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Placebo beverage was selected from commercially available, artificially flavored and colored fruit punches (Great Value fruit punch, Bentonville, AR) to match a closely as possible the color (red) of the TCJ.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •This study was a 12-week 2 x 2 crossover, randomized, placebo-controlled dietary intervention in overweight and obese participants (BMI>25.0 kg/m2) who are more likely to exhibit >1 of the 5 risk conditions associated with metabolic syndrome (MetS). BMI was the minimal criterion for recruitment.
排除标准
- •Participants were >18 years of age, not pregnant, not diabetic, with no unresolved infections or diseases (diabetes, CVD, IBD, cancer and liver disease), and nonsmokers. Histories of medication and dietary supplement use were collected and those taking anti-inflammatory or lipid-lowering medications were excluded.
研究组 & 干预措施
Placebo
Participants randomized to consume either placebo beverage or tart cherry juice at beginning of the study followed by a 2 week washout then switch over to the alternate beverage. Approximately half of participants began study consuming placebo beverage and the other half TCJ.
干预措施: Placebo (Dietary Supplement)
Tart cherry juice (TCJ)
Participants randomized to consume either placebo beverage or tart cherry juice at beginning of the study followed by a 2 week washout then switch over to the alternate beverage. Approximately half pf participants began study consuming placebo beverage and the other half TCJ.
干预措施: Tart cherry juice (Dietary Supplement)
结局指标
主要结局
TCJ and hsCRP
时间窗: 4 weeks
high-sensitivity C-reactive protein (hsCRP), a marker of inflammation
次要结局
- fasting triglycerides(4 weeks)
研究者
Keith Martin
Research Assistant Professor
University of Memphis