Diet ModificationS51NCT03885544
Effects of Consuming Red Meat on the Gut Microbiota in Young Adults
A study of Diet Modification, run by Purdue University at 1 site in United States.
Trial summary
The purpose of this study is to assess the impact of consuming unprocessed and processed red meat on gut microbiota in young healthy adults in a cross-over, randomized controlled feeding trial. Read more about this study
- Who is it for?
- Ages 20 to 35 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
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2018to 23 Mar 2020
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male or female,
- 20-35 years old,
- BMI 20.0-29.9 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 for 3 months prior (±3 kg); stable physical activity regimen 3 months prior;
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- medication use stable for 6 months prior and not using medications or supplements known to impact gut function;
- on-smoking; not drinking more than 2 alcoholic drinks per day;
- non-diabetic,
- no history of gastrointestinal disorders, surgeries or cancers;
- non-pregnant and not lactating.
- Participants must be willing and able to consume the prescribed diets (lacto-ovo vegetarian and omnivorous).
Who cannot join
- male or female < 20->35 years old,
- BMI <20.0- >29.9 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 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,
- history of gastrointestinal disorders, GI surgeries or GI cancers;
- pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the impact of consuming unprocessed and processed red meat on gut microbiota in young healthy adults in a cross-over, randomized controlled feeding trial.
Read the detailed description
The purpose of this study is to assess the impact of consuming processed and unprocessed red meat on gut microbiota in young healthy adults in a cross-over, randomized controlled feeding trial. The hypothesis is that compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, (1) consuming the LOV diet with unprocessed red meat or processed red meat (omnivorous diet) will shift the gut microbiota with greater abundance of the bacteria Lactobacillus and other SCFA producers such as Clostridium XIVa, and no increase of pathogenic bacteria. The concentration of SCFA in stools will also increase in subjects consuming the unprocessed red meat diet. Compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, (2) consuming the LOV diet with processed beef and pork (omnivorous diet) will result in a comparable shift in gut microbiota as unprocessed red meat, except for greater abundance of taxa Erysipelotrichaceae and lower abundance of Lachnospiraceae.
- Conditions
- Diet Modification
- Being tested
- Controlled Lacto-ovo vegetarian diet, Controlled Unprocessed red meat diet, Controlled processed red meat diet
- Keywords
- beef, pork, red meat, gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled Lacto-ovo vegetarian dietOther
Subjects will be randomized and assigned into an intervention to consume the controlled lacto-ovo vegetarian (LOV) diet for 3 weeks. All foods will be provided to subjects during the intervention. Each subject's energy requirement will be estimated using sex-specific equations published by the Institute of Medicine for weight maintenance during the intervention.
Controlled Unprocessed red meat dietOther
The unprocessed red meat diet will be the same as the LOV diet except that one 3-ounce portion of unprocessed red meat per day, 7 days per week (21 oz/wk) will be included. The unprocessed red meat will include beef tenderloin and pork loin. All foods will be provided to subjects during the intervention.
Controlled processed red meat dietOther
The processed red meat diet will be the same as the LOV diet except that one 3-ounce portion of processed red meat per day, 7 days per week (21 oz/wk) will be included. The processed red meat will include a variety of beef and pork luncheon meats with different methods of preservation. All foods will be provided to subjects during the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Controlled lacto-ovo vegetarian diet | Active comparator | Subjects will be randomized and assigned into an intervention to consume the controlled lacto-ovo vegetarian diet without red meat for 3 weeks. Receives: Other: Controlled Lacto-ovo vegetarian diet |
| Controlled unprocessed red meat diet | Experimental | Subjects will be randomized and assigned into an intervention to consume the controlled lacto-ovo vegetarian diet with unprocessed red meat for 3 weeks. Receives: Other: Controlled Unprocessed red meat diet |
| Controlled processed red meat diet | Experimental | Subjects will be randomized and assigned into an intervention to consume the controlled lacto-ovo vegetarian diet with processed red meat for 3 weeks. Receives: Other: Controlled processed red meat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota composition
The hypothesis is that compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, (1) consuming the LOV diet with unprocessed red meat or processed red meat (omnivorous diet) will shift the gut microbiota with greater abundance of the bacteria Lactobacillus and other SCFA producers such as Clostridium XIVa, and no increase of pathogenic bacteria. Compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, (2) consuming the LOV diet with processed beef and pork (omnivorous diet) will result in a comparable shift in gut microbiota as unprocessed red meat, except for greater abundance of taxa Erysipelotrichaceae and lower abundance of Lachnospiraceae.
Measured: 21 months. Stool samples will be obtained at the end of study weeks 3, 4, 7, 8, 11, 12, 15, 16, 19, 20, 23, and 24, which correspond to before and during the last 2 weeks of the three 3-wk controlled diet periods.
Concentrations of short chain fatty acids (SCFA)
The hypothesis is that compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, the concentration of SCFA in stools will also increase in subjects consuming the unprocessed or processed red meat diet.
Measured: 21 months. Stool samples will be obtained at the end of study weeks 3, 4, 7, 8, 11, 12, 15, 16, 19, 20, 23, and 24, which correspond to before and during the last 2 weeks of the three 3-wk controlled diet periods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start9 Jan 2018
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 24-week randomized controlled, crossover, single-blind study. Following a 5-wk pre-intervention baseline period, subjects will be randomly assigned to consume a controlled diet that either does not contain any red meat (lacto-ovo vegetarian, LOV), or contains unprocessed lean red meat, or contains processed lean red meat, for 3 weeks. After a 5-week dietary 'washout' period, they will consume one of the alternative diets for 3 weeks. After the second 5-week dietary 'washout' period, they will consume the remaining alternative diet for 3 weeks. Stool and fasting-state blood samples will be obtained at the end of study weeks 3, 4, 7, 8, 11, 12, 15, 16, 19, 20, 23, and 24, which correspond to before and during the last 2 weeks of the three 3-wk controlled diet periods. Consecutive 4-day 24-hour urine samples will be collected within the assessment weeks of each dietary 'washout' period and control diet period (study weeks 4, 8, 12, 16, 20, 24).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Wayne W Campbell, Ph.D., Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885544
- Sponsor's protocol ID
- 1709019738
- Acronym
- S51
- Status last verified
- Jul 2020
- First submitted
- 27 Mar 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Y, Lindemann SR, Cross TL, Tang M, Clark CM, Campbell WW. Effects of Adding Lean Red Meat to a U.S.-Style Healthy Vegetarian Dietary Pattern on Gut Microbiota and Cardiovascular Risk Factors in Young Adults: a Crossover Randomized Controlled Trial. J Nutr. 2023 May;153(5):1439-1452. doi: 10.1016/j.tjnut.2023.03.013. Epub 2023 Mar 14.
PubMed 36921804
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Consuming Red Meat on the Gut Microbiota in Young Adults
- ClinicalTrials.gov ID
- NCT03885544
- Acronym / sponsor ID
- S51 / 1709019738
- Conditions
- Diet Modification
- Keywords
- beef, pork, red meat, gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 21 Mar 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 purpose of this study is to assess the impact of consuming unprocessed and processed red meat on gut microbiota in young healthy adults in a cross-over, randomized controlled feeding trial.
Detailed description
The purpose of this study is to assess the impact of consuming processed and unprocessed red meat on gut microbiota in young healthy adults in a cross-over, randomized controlled feeding trial. The hypothesis is that compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, (1) consuming the LOV diet with unprocessed red meat or processed red meat (omnivorous diet) will shift the gut microbiota with greater abundance of the bacteria Lactobacillus and other SCFA producers such as Clostridium XIVa, and no increase of pathogenic bacteria. The concentration of SCFA in stools will also increase in subjects consuming the unprocessed red meat diet. Compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, (2) consuming the LOV diet with processed beef and pork (omnivorous diet) will result in a comparable shift in gut microbiota as unprocessed red meat, except for greater abundance of taxa Erysipelotrichaceae and lower abundance of Lachnospiraceae.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a 24-week randomized controlled, crossover, single-blind study. Following a 5-wk pre-intervention baseline period, subjects will be randomly assigned to consume a controlled diet that either does not contain any red meat (lacto-ovo vegetarian, LOV), or contains unprocessed lean red meat, or contains processed lean red meat, for 3 weeks. After a 5-week dietary 'washout' period, they will consume one of the alternative diets for 3 weeks. After the second 5-week dietary 'washout' period, they will consume the remaining alternative diet for 3 weeks. Stool and fasting-state blood samples will be obtained at the end of study weeks 3, 4, 7, 8, 11, 12, 15, 16, 19, 20, 23, and 24, which correspond to before and during the last 2 weeks of the three 3-wk controlled diet periods. Consecutive 4-day 24-hour urine samples will be collected within the assessment weeks of each dietary 'washout' period and control diet period (study weeks 4, 8, 12, 16, 20, 24).
| Arm | Type | Receives |
|---|---|---|
| Controlled lacto-ovo vegetarian diet | Active comparator | Other: Controlled Lacto-ovo vegetarian dietSubjects will be randomized and assigned into an intervention to consume the controlled lacto-ovo vegetarian diet without red meat for 3 weeks. |
| Controlled unprocessed red meat diet | Experimental | Other: Controlled Unprocessed red meat dietSubjects will be randomized and assigned into an intervention to consume the controlled lacto-ovo vegetarian diet with unprocessed red meat for 3 weeks. |
| Controlled processed red meat diet | Experimental | Other: Controlled processed red meat dietSubjects will be randomized and assigned into an intervention to consume the controlled lacto-ovo vegetarian diet with processed red meat for 3 weeks. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- male or female,
- 20-35 years old,
- BMI 20.0-29.9 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;
Key exclusion criteria (12 listed)
- male or female < 20->35 years old,
- BMI <20.0- >29.9 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 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 Lacto-ovo vegetarian dietSubjects will be randomized and assigned into an intervention to consume the controlled lacto-ovo vegetarian (LOV) diet for 3 weeks. All foods will be provided to subjects during the intervention. Each subject's energy requirement will be estimated using sex-specific equations published by the Institute of Medicine for weight maintenance during the intervention. | Other | Controlled lacto-ovo vegetarian diet |
| Controlled Unprocessed red meat dietThe unprocessed red meat diet will be the same as the LOV diet except that one 3-ounce portion of unprocessed red meat per day, 7 days per week (21 oz/wk) will be included. The unprocessed red meat will include beef tenderloin and pork loin. All foods will be provided to subjects during the intervention. | Other | Controlled unprocessed red meat diet |
| Controlled processed red meat dietThe processed red meat diet will be the same as the LOV diet except that one 3-ounce portion of processed red meat per day, 7 days per week (21 oz/wk) will be included. The processed red meat will include a variety of beef and pork luncheon meats with different methods of preservation. All foods will be provided to subjects during the intervention. | Other | Controlled processed red meat diet |
Primary outcome
Changes in gut microbiota composition
Time frame: 21 months. Stool samples will be obtained at the end of study weeks 3, 4, 7, 8, 11, 12, 15, 16, 19, 20, 23, and 24, which correspond to before and during the last 2 weeks of the three 3-wk controlled diet periods.
The hypothesis is that compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, (1) consuming the LOV diet with unprocessed red meat or processed red meat (omnivorous diet) will shift the gut microbiota with greater abundance of the bacteria Lactobacillus and other SCFA producers such as Clostridium XIVa, and no increase of pathogenic bacteria. Compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, (2) consuming the LOV diet with processed beef and pork (omnivorous diet) will result in a comparable shift in gut microbiota as unprocessed red meat, except for greater abundance of taxa Erysipelotrichaceae and lower abundance of Lachnospiraceae.
Concentrations of short chain fatty acids (SCFA)
Time frame: 21 months. Stool samples will be obtained at the end of study weeks 3, 4, 7, 8, 11, 12, 15, 16, 19, 20, 23, and 24, which correspond to before and during the last 2 weeks of the three 3-wk controlled diet periods.
The hypothesis is that compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, the concentration of SCFA in stools will also increase in subjects consuming the unprocessed or processed red meat diet.
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 14 Jul 2020.
- Derived from this study: PubMed 36921804Wang Y, Lindemann SR, Cross TL, Tang M, Clark CM, Campbell WW. Effects of Adding Lean Red Meat to a U.S.-Style Healthy Vegetarian Dietary Pattern on Gut Microbiota and Cardiovascular Risk Factors in Young Adults: a Crossover Randomized Controlled Trial. J Nutr. 2023 May;153(5):1439-1452. doi: 10.1016/j.tjnut.2023.03.013. Epub 2023 Mar 14.
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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, Ph.D. 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 12 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 14 Jul 2020. 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?
Changes in gut microbiota composition (time frame: 21 months. Stool samples will be obtained at the end of study weeks 3, 4, 7, 8, 11, 12, 15, 16, 19, 20, 23, and 24, which correspond to before and during the last 2 weeks of the three 3-wk controlled diet periods.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03885544, which also lists 1 linked publication.
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 14 Jul 2020.