Antimicrobial-free Production of Beef Cattle's Affect on Gut Microbiome
- Conditions
- Diet Modification
- Interventions
- Other: Controlled diet with beef raised without antibioticsOther: Controlled diet with beef produced in conventional systems
- Registration Number
- NCT04023604
- Lead Sponsor
- Purdue University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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;
- Smoking;
- Drinking more than 2 alcoholic drinks per day;
- Diabetic;
- A history of gastrointestinal disorders, GI surgeries or GI cancers;
- Pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Controlled diet with beef raised without antibiotics Controlled diet with beef raised without antibiotics Subjects will be randomized and assigned to consume the U.S. Healthy Diet Diets with beef produced in RWA (raised without antibiotics) systems for three weeks. Controlled diet with beef produced in conventional systems Controlled diet with beef produced in conventional systems Subjects will be randomized and assigned to consume the U.S. Healthy Diet Diets with beef produced in conventional systems for three weeks.
- Primary Outcome Measures
Name Time Method Differences in the resistome and microbiome 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
- Secondary Outcome Measures
Name Time Method Level of fasting blood pressure 2 years The hypothesis is that there is no difference in blood pressure in people eating beef derived from cattle raised conventionally vs. those eating beef produced in RWA systems.
Level of fasting serum insulin 2 years The hypothesis is that there is no difference in fasting serum insulin in people eating beef derived from cattle raised conventionally vs. those eating beef produced in RWA systems.
Size of lipoprotein particle 2 years The hypothesis is that there is no difference in lipoprotein particle size in people eating beef derived from cattle raised conventionally vs. those eating beef produced in RWA systems
Level of fasting serum glucose 2 years The hypothesis is that there is no difference in fasting serum glucose in people eating beef derived from cattle raised conventionally vs. those eating beef produced in RWA systems.
Trial Locations
- Locations (1)
Dept. Foods and Nutrition, Purdue University
🇺🇸West Lafayette, Indiana, United States