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

NCT04023604 | Completed

• 1 other identifier: 1905022180
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Modification

Keywords

antibiotics; gut microbiome; antimicrobial resistance; beef

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Level of fasting blood pressure

  2 years

• Level of fasting serum insulin

  2 years

• Level of fasting serum glucose

  2 years

• Size of lipoprotein particle

  2 years

Other Outcomes (1)

• Questionnaire score of mood and health and well being

  2 years

Study Arms (2)

Controlled diet with beef raised without antibiotics

ACTIVE COMPARATOR

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.

Other: Controlled diet with beef raised without antibiotics

Controlled diet with beef produced in conventional systems

EXPERIMENTAL

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

Other: Controlled diet with beef produced in conventional systems

Interventions

Controlled diet with beef raised without antibiotics 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 raised without antibiotics

Controlled diet with beef produced in conventional systems 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.

Controlled diet with beef produced in conventional systems

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Purdue University: lead
• Colorado State University: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Dept. Foods and Nutrition, Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Wayne W Campbell, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 17, 2019
• Study Start: January 4, 2021
• Primary Completion: December 15, 2021
• Study Completion: March 4, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

US (1)