Does Antimicrobial-free Production of Beef Cattle Reduce Foodborne Transmission of Resistant Bacteria to Human Consumers?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Differences in the resistome and microbiome
研究概览
简要总结
The primary purpose of this study is to assess whether consuming foods from animals raised with antimicrobial medications influences gut health in adults between the ages of 21-69 years old. Antimicrobial medications are commonly used to help animals avoid infections while growing.
详细描述
The researchers plan to investigate differences in the resistome (i.e., populations of antimicrobial resistance genes) and microbiome (populations of bacteria) in feces obtained from people when they consume diets containing beef derived from cattle raised conventionally (i.e. using antimicrobial drugs(AMDs)) vs. those produced in raised without antibiotics (RWA) systems. In addition, the researchers will investigate whether specific antimicrobial resistant (AMR) genes are transmitted from food to people.
The hypothesis is that beef is not a significant source of resistant bacteria, and there is no difference in the likelihood of gut colonization with resistant bacteria in people eating beef derived from cattle raised conventionally (i.e. using AMDs) vs. those eating beef produced in RWA systems.
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
- 21 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 21-69 years old;
- •BMI 22.0-34.9 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 (± 4 kg in previous 3 mo);
- •Medication use stable for 6 months prior and not using medications or supplements known to impact gut function;
- •No use of topical, oral or parenteral antibiotic medications in previous 6 months.
- •Non-smoking;
- •Physical activity regimen stable for 3 months prior;
- •Not drinking more than 2 alcoholic drinks per day;
- •No history of gastrointestinal disorders, surgeries or cancers;
- •Non-pregnant and not lactating
- •No acute illness and non-diabetic;
- •Willing and able to consume the prescribed diets that may include meat, dairy and gluten-containing foods and beverages.
排除标准
- •Male or female, < 20 or >70 years old;
- •BMI < 21.9- >35 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 blood pressure >140 mmHg, diastolic blood pressure >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;
- •A history of gastrointestinal disorders, GI surgeries or GI cancers;
- •Pregnant or lactating
结局指标
主要结局
Differences in the resistome and microbiome
时间窗: 2 years
The resistome and microbiome of rinsates will be obtained from dietary components, and feces collected from the particpants. Researchers will sequence all of the published AMR genes. Microbiome data will be obtained from 16s rRNA gene sequencing to produce amplicons of the V4 region of 16S rRNA genes. Statistical analyses will be conducted of microbial features to assess whether microbial/resistome communities diverge between the two groups. Additionally, foodborne transmission of AMR genes with discriminatory SNP("DNA fingerprints") profiles will be investigated through the food chain into dietary trial participants to identify highly discriminatory patterns in individual genes, or discriminatory profiles in gene sets. Hypothesis: beef is not a significant source of resistant bacteria and there is no difference in the likelihood of gut colonization with resistant bacteria in people eating beef derived from cattle raised conventionally vs beef produced in RWA systems
次要结局
- Level of fasting blood pressure(2 years)
- Level of fasting serum insulin(2 years)
- Size of lipoprotein particle(2 years)
- Level of fasting serum glucose(2 years)
研究者
Wayne Campbell
Principal Investigator
Purdue University