Clinical trial NCT04023604: Antimicrobial-free Production of Beef Cattle's Affect on Gut Microbiome
Official title: Does Antimicrobial-free Production of Beef Cattle Reduce Foodborne Transmission of Resistant Bacteria to Human Consumers?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Keywords: antibiotics
gut microbiome
antimicrobial resistance
beef
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Colorado State University
name: University of Minnesota
First posted: 2019-07-17
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a 16-week randomized, cross-over, controlled, blinded study. During weeks 2 and 9, participants usual, unrestricted dietary intakes will be assessed. At week 3 the participants will be randomized and assigned to consume either the controlled U.S. Healthy Eating Pattern with beef produced in conventional systems or to an identical controlled U.S. Healthy Eating Patter with beef produced in RWA (raised without antibiotics) systems. Week 10 will be the second 3- week long dietary intervention period. A total of 14 stool samples will be collected during the study (two after baseline, washout 1 and washout 2, and 4 during the two dietary interventions). Two fasting state serum samples and a psychological questionnaire will be collected during study weeks 2, 5, 9, and 12.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Differences in the resistome and microbiome
timeFrame: 2 years
Secondary outcomes:
measure: Level of fasting blood pressure
timeFrame: 2 years
measure: Level of fasting serum insulin
timeFrame: 2 years
measure: Level of fasting serum glucose
timeFrame: 2 years
measure: Size of lipoprotein particle
timeFrame: 2 years
Other outcomes:
measure: Questionnaire score of mood and health and well being
timeFrame: 2 years
Locations:
city: West Lafayette
country: United States
facility: Dept. Foods and Nutrition, Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne W Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References: