Diet ModificationS54NCT04023604
Antimicrobial-free Production of Beef Cattle's Affect on Gut Microbiome
A study of Diet Modification, run by Purdue University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 4 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept. Foods and Nutrition, Purdue University
West Lafayette, Indiana, 47907
About this study
Official title: Does Antimicrobial-free Production of Beef Cattle Reduce Foodborne Transmission of Resistant Bacteria to Human Consumers?
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.
Read the 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.
- Conditions
- Diet Modification
- Being tested
- Controlled diet with beef raised without antibiotics, Controlled diet with beef produced in conventional systems
- Keywords
- antibiotics, gut microbiome, antimicrobial resistance, beef
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled diet with beef raised without antibioticsOther
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 produced in conventional systemsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Controlled diet with beef produced in conventional systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (4)
Level of fasting blood pressure
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.
Measured: 2 years
Level of fasting serum insulin
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.
Measured: 2 years
Level of fasting serum glucose
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.
Measured: 2 years
Size of lipoprotein particle
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start4 Jan 2021
- Primary completion15 Dec 2021
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University, University of Minnesota
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Wayne W Campbell, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023604
- Sponsor's protocol ID
- 1905022180
- Acronym
- S54
- Status last verified
- Sep 2022
- First submitted
- 28 Jun 2019
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Antimicrobial-free Production of Beef Cattle Reduce Foodborne Transmission of Resistant Bacteria to Human Consumers?
- ClinicalTrials.gov ID
- NCT04023604
- Acronym / sponsor ID
- S54 / 1905022180
- Conditions
- Diet Modification
- Keywords
- antibiotics, gut microbiome, antimicrobial resistance, beef
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Colorado State University, University of Minnesota
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Controlled diet with beef raised without antibiotics | Active comparator | Other: Controlled diet with beef raised without antibioticsSubjects 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. |
| Controlled diet with beef produced in conventional systems | Experimental | Other: Controlled diet with beef produced in conventional systemsSubjects will be randomized and assigned to consume the U.S. Healthy Diet Diets with beef produced in conventional systems for three weeks. |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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);
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled diet with beef raised without antibioticsThe 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. | Other | Controlled diet with beef raised without antibiotics |
| Controlled diet with beef produced in conventional systemsThe 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. | Other | Controlled diet with beef produced in conventional systems |
Primary outcome
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
4 secondary outcomes
Level of fasting blood pressure
Time frame: 2 years
Level of fasting serum insulin
Time frame: 2 years
Level of fasting serum glucose
Time frame: 2 years
Size of lipoprotein particle
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne W Campbell, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diet Modification, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the resistome and microbiome (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.