NCT04149418已完成不适用
Anti-inflammatory Activity of Yogurt Mediated by the Intestine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Th17 proportion
研究概览
简要总结
The objective of this study is to conduct a randomized cross-over dietary intervention in adult women who are overweight or obese to compare how yogurt and a control food affect biomarkers of inflammation and intestinal health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy premenopausal women age 21-55
- •BMI ≥ 25 kg/m2
- •not taking medication to control hypertension (e.g. anti-hypertensives or diuretics)
- •resting blood pressure <140/90 mmHg
- •stable body weight for past two months
- •willing to maintain a normal exercise level (in general)
- •willing to avoid exercise and smoking (or other forms of nicotine intake) for 24 h prior to blood collection
- •willing to avoid caffeine for 12 h before study visits
- •willing to fast 12 h prior to study visits
- •willing to avoid dietary supplements, yogurt and probiotic-containing foods (as necessary) and consume 12 oz. of yogurt and the control food per day (as necessary) for the duration of the study
排除标准
- •self-reported previous diagnoses of an inflammatory disease (e.g. inflammatory bowel disease, asthma, arthritis), CVD, diabetes, current cancer treatment (i.e., chemotherapy, radiation therapy)
- •have used oral antibiotics in the prior 21 days before sample collection
- •actively trying to lose weight
- •regularly taking anti-inflammatory drugs
- •vegetarian or allergic to soy or dairy
- •are pregnant, lactating, or trying to become pregnant
结局指标
主要结局
Change in Th17 proportion
时间窗: Baseline, Week 4, Week 8, Week 12
Change in proportions of circulating Th17 cells (change in control vs. change in yogurt)
次要结局
- Change in Treg subpopulation(Baseline, Week 4, Week 8, Week 12)
- Change in Th17 subpopulation (IL-17A+ IFNδ+)(Baseline, Week 4, Week 8, Week 12)
- Change in plasma tumor necrosis factor alpha (TNF-alpha)(Baseline, Week 4, Week 8, Week 12)
- Change in plasma interleukin-17A (IL-17A)(Baseline, Week 4, Week 8, Week 12)
- Change in fecal interleukin 1 alpha (IL-1alpha)(Baseline, Week 4, Week 8, Week 12)
- Change in Th17 subpopulation (IL-17A+ FoxP3+)(Baseline, Week 4, Week 8, Week 12)
- Change in plasma interleukin-22 (IL-22)(Baseline, Week 4, Week 8, Week 12)
- Change in plasma interleukin-10 (IL-10)(Baseline, Week 4, Week 8, Week 12)
- Change in retinoic acid receptor-related orphan nuclear receptor gamma T (RORgammaT) expression(Baseline, Week 4, Week 8, Week 12)
- Change in Treg proportion(Baseline, Week 4, Week 8, Week 12)
- Change in plasma interferon gamma (IFN-gamma)(Baseline, Week 4, Week 8, Week 12)
- Change in plasma interleukin-4(Baseline, Week 4, Week 8, Week 12)
- Change in plasma transforming growth factor beta (TGF-beta)(Baseline, Week 4, Week 8, Week 12)
- Change in Forkhead box P3 (FoxP3) expression(Baseline, Week 4, Week 8, Week 12)
- Change in fecal calprotectin(Baseline, Week 4, Week 8, Week 12)
- Change in Th17 subpopulation (IL-17A+ TNFα+)(Baseline, Week 4, Week 8, Week 12)
- Change in Th17 subpopulation (IL-17A+ IL-10+)(Baseline, Week 4, Week 8, Week 12)
- Change in fecal tumor necrosis factor alpha (TNF-alpha)(Baseline, Week 4, Week 8, Week 12)
- Change in fecal interleukin 1beta (IL-1beta)(Baseline, Week 4, Week 8, Week 12)
- Change in fecal interleukin-17A (IL-17A)(Baseline, Week 4, Week 8, Week 12)
- Change in Th17 subpopulation (IL-17A+ IL-22+)(Baseline, Week 4, Week 8, Week 12)
- Change in plasma interleukin-6 (IL-6)(Baseline, Week 4, Week 8, Week 12)
- Change in fecal interleukin-6 (IL-6)(Baseline, Week 4, Week 8, Week 12)
研究者
研究点 (2)
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