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出境医 / 临床实验 / Antimicrobial-free Production of Beef Cattle's Affect on Gut Microbiome (S54)
Antimicrobial-free Production of Beef Cattle's Affect on Gut Microbiome (S54)
Study Description
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.
Study Design
| 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? |
| Actual Study Start Date : | January 4, 2021 |
| Estimated Primary Completion Date : | August 2022 |
| Estimated Study Completion Date : | September 2022 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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.
- 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.
- 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.
- 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:
- 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.
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Jan K Green | 765-496-6342 | jkgreen@purdue.edu | |
| Contact: Erica R Hill | 708-291-0485 | hill155@purdue.edu |
Locations
| United States, Indiana | |
| Dept. Foods and Nutrition, Purdue University | Recruiting |
| West Lafayette, Indiana, United States, 47907 | |
| Contact: Wayne W Campbell, PhD 765-494-8236 campbeww@purdue.edu | |
| Contact: Jan Green 765-496-6342 tjkgreen@purdue.edu | |
| Principal Investigator: Wayne W Campbell, PhD | |
Sponsors and Collaborators
Purdue University
Colorado State University
University of Minnesota
Investigators
| Principal Investigator: | Wayne W Campbell, PhD | Purdue University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 28, 2019 | ||||||||
| First Posted Date ICMJE | July 17, 2019 | ||||||||
| Last Update Posted Date | March 24, 2021 | ||||||||
| Actual Study Start Date ICMJE | January 4, 2021 | ||||||||
| Estimated Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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
|
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| Original Primary Outcome Measures ICMJE |
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
|
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
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.
|
||||||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Antimicrobial-free Production of Beef Cattle's Affect on Gut Microbiome | ||||||||
| Official Title ICMJE | Does Antimicrobial-free Production of Beef Cattle Reduce Foodborne Transmission of Resistant Bacteria to Human Consumers? | ||||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | 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 |
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| Condition ICMJE | Diet Modification | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
35 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | September 2022 | ||||||||
| Estimated Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 21 Years to 69 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04023604 | ||||||||
| Other Study ID Numbers ICMJE | 1905022180 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Wayne Campbell, Purdue University | ||||||||
| Study Sponsor ICMJE | Purdue University | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Purdue University | ||||||||
| Verification Date | March 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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