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临床试验/NCT03885544
NCT03885544已完成不适用

Effects of Consuming Red Meat on the Gut Microbiota in Young Adults

Purdue University2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Changes in gut microbiota composition

研究概览

简要总结

The purpose of this study is to assess the impact of consuming unprocessed and processed red meat on gut microbiota in young healthy adults in a cross-over, randomized controlled feeding trial.

详细描述

The purpose of this study is to assess the impact of consuming processed and unprocessed red meat on gut microbiota in young healthy adults in a cross-over, randomized controlled feeding trial. The hypothesis is that compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, (1) consuming the LOV diet with unprocessed red meat or processed red meat (omnivorous diet) will shift the gut microbiota with greater abundance of the bacteria Lactobacillus and other SCFA producers such as Clostridium XIVa, and no increase of pathogenic bacteria. The concentration of SCFA in stools will also increase in subjects consuming the unprocessed red meat diet. Compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, (2) consuming the LOV diet with processed beef and pork (omnivorous diet) will result in a comparable shift in gut microbiota as unprocessed red meat, except for greater abundance of taxa Erysipelotrichaceae and lower abundance of Lachnospiraceae.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • male or female,
  • 20-35 years old,
  • BMI 20.0-29.9 kg/m2,
  • fasting serum total cholesterol <240 mg/dL, low-density lipoprotein cholesterol <160 mg/dL, triglycerides <400 mg/dL, and glucose <110 mg/dL;
  • systolic/diastolic blood pressure <140/90 mmHg;
  • body weight stable for 3 months prior (±3 kg); stable physical activity regimen 3 months prior;
  • medication use stable for 6 months prior and not using medications or supplements known to impact gut function;
  • on-smoking; not drinking more than 2 alcoholic drinks per day;
  • non-diabetic,
  • no history of gastrointestinal disorders, surgeries or cancers;
  • non-pregnant and not lactating.
  • Participants must be willing and able to consume the prescribed diets (lacto-ovo vegetarian and omnivorous).

排除标准

  • male or female < 20->35 years old,
  • BMI <20.0- >29.9 kg/m2,
  • fasting serum total cholesterol >240 mg/dL, low-density lipoprotein cholesterol >160 mg/dL, triglycerides >400 mg/dL, and glucose >110 mg/dL;
  • systolic/diastolic blood pressure >140/90 mmHg;
  • body weight stable for <3 months prior (±3 kg);
  • stable physical activity regimen < 3 months prior;
  • medication use unstable for 6 months prior and using medications or supplements known to impact gut function;
  • drinking more than 2 alcoholic drinks per day;
  • diabetic,
  • history of gastrointestinal disorders, GI surgeries or GI cancers;
  • pregnant or lactating.

结局指标

主要结局

Changes in gut microbiota composition

时间窗: 21 months. Stool samples will be obtained at the end of study weeks 3, 4, 7, 8, 11, 12, 15, 16, 19, 20, 23, and 24, which correspond to before and during the last 2 weeks of the three 3-wk controlled diet periods.

The hypothesis is that compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, (1) consuming the LOV diet with unprocessed red meat or processed red meat (omnivorous diet) will shift the gut microbiota with greater abundance of the bacteria Lactobacillus and other SCFA producers such as Clostridium XIVa, and no increase of pathogenic bacteria. Compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, (2) consuming the LOV diet with processed beef and pork (omnivorous diet) will result in a comparable shift in gut microbiota as unprocessed red meat, except for greater abundance of taxa Erysipelotrichaceae and lower abundance of Lachnospiraceae.

Concentrations of short chain fatty acids (SCFA)

时间窗: 21 months. Stool samples will be obtained at the end of study weeks 3, 4, 7, 8, 11, 12, 15, 16, 19, 20, 23, and 24, which correspond to before and during the last 2 weeks of the three 3-wk controlled diet periods.

The hypothesis is that compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, the concentration of SCFA in stools will also increase in subjects consuming the unprocessed or processed red meat diet.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wayne Campbell

Principal Investigator

Purdue University

研究点 (2)

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