- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04023604
Antimicrobial-free Production of Beef Cattle's Affect on Gut Microbiome (S54)
Does Antimicrobial-free Production of Beef Cattle Reduce Foodborne Transmission of Resistant Bacteria to Human Consumers?
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
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West Lafayette, Indiana, United States, 47907
- Dept. Foods and Nutrition, Purdue University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in the resistome and microbiome
Time Frame: 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 years
|
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.
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2 years
|
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.
|
2 years
|
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
|
2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1905022180
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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