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

Diet Modification Clinical Trial

— S54  

Official title:

Does Antimicrobial-free Production of Beef Cattle Reduce Foodborne Transmission of Resistant Bacteria to Human Consumers?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023604
• Other study ID #: 1905022180
• Status: Completed
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: March 4, 2022

Study information

• Verified date: September 2022
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 4, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Modification

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Dept. Foods and Nutrition, Purdue University	West Lafayette	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Purdue University	Colorado State University, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questionnaire score of mood and health and well being	The POMS (Profile of Mood States) Questionnaire is a psychological rating scale to assess distinct mood states. There is a total of 35 questions using a five point scale ranging from "not at all" to "extremely" indicating the range of mood swings over a period of time.; The Optum SF-36v2 (Short Form 36 question Version 2) Health Survey measures the functional health and wellbeing of a participant. SF-36v2 consists of eight scaled scores which are the weighted sums of the questions in their section. Each scale is transformed into a 0-100 scales, with the assumption that each questions carries equal weight (the lower the score the more disability, the higher the score the less disability).; The hypothesis is that there is no difference in mood and health and wellbeing in people eating beef derived from cattle raised conventionally vs. those eating beef produced in RWA systems.	2 years
Primary	Differences in the resistome and microbiome	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	2 years
Secondary	Level of fasting blood pressure	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.	2 years
Secondary	Level of fasting serum insulin	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.	2 years
Secondary	Level of fasting serum glucose	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.	2 years
Secondary	Size of lipoprotein particle	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	2 years