Antimicrobial-free Production of Beef Cattle's Affect on Gut Microbiome (S54)

Purdue University

Status: Completed

Conditions: Diet Modification

Treatments: Other: Controlled diet with beef raised without antibiotics; Other: Controlled diet with beef produced in conventional systems

Study type: Interventional

Funder types: Other

Identifiers

NCT04023604

1905022180

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 21 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Controlled diet with beef raised without antibiotics

Active Comparator group

Description:

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.

Treatment:

Other: Controlled diet with beef raised without antibiotics

Controlled diet with beef produced in conventional systems

Experimental group

Description:

Subjects will be randomized and assigned to consume the U.S. Healthy Diet Diets with beef produced in conventional systems for three weeks.

Treatment:

Other: Controlled diet with beef produced in conventional systems