Effects of Consuming Red Meat on the Gut Microbiota in Young Adults

NCT ID: NCT03885544

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-09
• Study Completion Date: 2020-03-23

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Controlled Lacto-ovo vegetarian diet

Intervention Type: OTHER

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 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.

Group Type: EXPERIMENTAL

Controlled Unprocessed red meat diet

Intervention Type: OTHER

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 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.

Group Type: EXPERIMENTAL

Controlled processed red meat diet

Intervention Type: OTHER

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.

Interventions

Controlled Lacto-ovo vegetarian diet

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.

Intervention Type: OTHER

Controlled Unprocessed red meat diet

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.

Intervention Type: OTHER

Controlled processed red meat diet

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Wayne Campbell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wayne W Campbell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

Purdue University

West Lafayette, Indiana, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36921804 (View on PubMed)

Other Identifiers

1709019738

Identifier Type: -

Identifier Source: org_study_id