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

NCT03885544 | Completed

• 1 other identifier: 1709019738
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Modification

Keywords

beef; pork; red meat; gut microbiota

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 Outcomes (1)

• metabolomics analysis

  Undecided.

Study Arms (3)

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.

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.

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.

Other: Controlled processed red meat diet

Interventions

Controlled Lacto-ovo vegetarian diet 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 lacto-ovo vegetarian diet

Controlled Unprocessed red meat diet 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 unprocessed red meat diet

Controlled processed red meat diet 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.

Controlled processed red meat diet

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male or female,
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

• 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.

  PMID: 36921804 DERIVED

Study Officials

• Wayne W Campbell, Ph.D.

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: March 21, 2019
• Study Start: January 9, 2018
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

US (1)