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临床试验/NCT01686204
NCT01686204已完成不适用

Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2012年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
2
主要终点
Plasma soluble cluster of differentiation 14 (sCD14)

研究概览

简要总结

The main objective of this work is to conduct a clinical trial in obese and non-obese individuals testing the ability of low-fat dairy yogurt to improve gastrointestinal health and reduce chronic inflammation. Our central hypothesis is that short and long-term consumption of low-fat dairy yogurt will reduce inflammation to a greater extent in obese individuals by improving intestinal barrier function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • premenopausal women
  • BMI from 18.5-27 and 30-40 kg/m2
  • resting blood pressure <140/90 mmHg
  • not taking medication to control hypertension
  • stable body weight for the previous 2 months
  • willing to maintain a normal exercise level and avoid exercise 24 h prior to blood sampling
  • willing to avoid yogurt and probiotic-containing foods or consume 2 servings of yogurt for the duration of the study

排除标准

  • previous diagnoses of cardiovascular disease (CVD), diabetes, or arthritis (except for osteo-arthritis)
  • currently being treated for cancer (i.e., chemotherapy, radiation therapy)
  • prescribed estrogen replacement therapy
  • practicing weight-loss, vegetarian, kosher, or vegan diets
  • currently taking dietary supplements
  • exceed alcohol consumption more than moderate drinking (1 drink/day or a total of 7/week)
  • actively using antibiotics
  • taking anti-inflammatory drugs
  • have allergies to soy, egg or milk
  • perimenopausal or menopausal symptoms

研究组 & 干预措施

Non-obese individuals

Active Comparator

Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks.

干预措施: Low fat dairy yogurt (Other)

Non-obese individuals

Active Comparator

Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks.

干预措施: Soy pudding (Other)

Obese individuals

Experimental

Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks.

干预措施: Low fat dairy yogurt (Other)

Obese individuals

Experimental

Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks.

干预措施: Soy pudding (Other)

结局指标

主要结局

Plasma soluble cluster of differentiation 14 (sCD14)

时间窗: 0, 3, 6, and 9 wk

Fasting plasma sCD14 (change from baseline)

次要结局

  • Fasting plasma interleukin-6 (IL-6)(0, 3, 6, 9 wk)
  • Postprandial sCD14(0 and 9 wk)
  • Postprandial interleukin-6 (IL-6)(0 and 9 wk)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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