- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03885544
Effects of Consuming Red Meat on the Gut Microbiota in Young Adults (S51)
July 10, 2020 updated by: Wayne Campbell, Purdue University
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Purdue University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
- 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).
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Controlled lacto-ovo vegetarian diet
Subjects will be randomized and assigned into an intervention to consume the controlled lacto-ovo vegetarian diet without red meat for 3 weeks.
|
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.
|
EXPERIMENTAL: Controlled unprocessed red meat diet
Subjects will be randomized and assigned into an intervention to consume the controlled lacto-ovo vegetarian diet with unprocessed red meat for 3 weeks.
|
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.
|
EXPERIMENTAL: Controlled processed red meat diet
Subjects will be randomized and assigned into an intervention to consume the controlled lacto-ovo vegetarian diet with processed red meat for 3 weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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)
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.
|
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.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
metabolomics analysis
Time Frame: Undecided.
|
Saves of blood, urine, and stool samples will be kept for possible further metabolomics and foodomics analyses.
|
Undecided.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 9, 2018
Primary Completion (ACTUAL)
March 23, 2020
Study Completion (ACTUAL)
March 23, 2020
Study Registration Dates
First Submitted
March 27, 2018
First Submitted That Met QC Criteria
March 19, 2019
First Posted (ACTUAL)
March 21, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 14, 2020
Last Update Submitted That Met QC Criteria
July 10, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1709019738
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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