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

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ClinicalTrials.gov Identifier: NCT04023604
Recruitment Status : Not yet recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborators:
Colorado State University
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Wayne Campbell, Purdue University

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.

Condition or disease Intervention/treatment Phase
Diet Modification Other: Controlled diet with beef raised without antibiotics Other: Controlled diet with beef produced in conventional systems Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Does Antimicrobial-free Production of Beef Cattle Reduce Foodborne Transmission of Resistant Bacteria to Human Consumers?
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: 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.
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.

Experimental: 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.
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.




Primary Outcome Measures :
  1. Differences in the resistome and microbiome [ Time Frame: 2 years ]
    DNA from feces will be compared to DNA from rinsates and ground meat products. The researchers will then 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 different treatment levels. Additionally, foodborne transmission of AMR genes with discriminatory SNP("DNA fingerprints") profiles will be investigated through the food chain into dietary trial participants via network analysis at the SNP level, 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


Secondary Outcome Measures :
  1. Level of fasting blood pressure [ Time Frame: 2 years ]
    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. Level of fasting serum insulin [ Time Frame: 2 years ]
    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.

  3. Level of fasting serum glucose [ Time Frame: 2 years ]
    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.

  4. Size of lipoprotein particle [ Time Frame: 2 years ]
    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


Other Outcome Measures:
  1. Questionnaire score of mood and health and well being [ Time Frame: 2 years ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023604


Contacts
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Contact: Jan K Green 765-496-6342 jkgreen@purdue.edu
Contact: Erica R Hill 708-291-0485 hill155@purdue.edu

Sponsors and Collaborators
Purdue University
Colorado State University
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Wayne W Campbell, PhD Purdue University

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Responsible Party: Wayne Campbell, Principal Investigator, Purdue University
ClinicalTrials.gov Identifier: NCT04023604     History of Changes
Other Study ID Numbers: 1905022180
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wayne Campbell, Purdue University:
antibiotics
gut microbiome
antimicrobial resistance
beef

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents