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

NCT ID: NCT04023604

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2022-03-04

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.

Conditions

Diet Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Controlled diet with beef raised without antibiotics

Intervention Type: OTHER

The controlled diet with beef raised without antibiotics will follow the Dietary Guidelines for American's recommendations. All foods and beverages will be provided during intervention to achieve the desired eating pattern. Beef included in this diet were raised without antibiotics.

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.

Group Type: EXPERIMENTAL

Controlled diet with beef produced in conventional systems

Intervention Type: OTHER

The controlled diet with beef raised without antibiotics will follow the Dietary Guidelines for American's recommendations. All foods and beverages will be provided during intervention to achieve the desired eating pattern. Beef included in this diet were raised with antibiotics.

Interventions

Controlled diet with beef raised without antibiotics

The controlled diet with beef raised without antibiotics will follow the Dietary Guidelines for American's recommendations. All foods and beverages will be provided during intervention to achieve the desired eating pattern. Beef included in this diet were raised without antibiotics.

Intervention Type: OTHER

Controlled diet with beef produced in conventional systems

The controlled diet with beef raised without antibiotics will follow the Dietary Guidelines for American's recommendations. All foods and beverages will be provided during intervention to achieve the desired eating pattern. Beef included in this diet were raised with antibiotics.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colorado State University

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Wayne Campbell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wayne W Campbell, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

Dept. Foods and Nutrition, Purdue University

West Lafayette, Indiana, United States

Countries

United States

Other Identifiers

1905022180

Identifier Type: -

Identifier Source: org_study_id