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Completed

NCT Number: NCT03885544

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

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.

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Key information

Conditions

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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 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.

Primary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. metabolomics analysis

    Time frame: Undecided.

    Saves of blood, urine, and stool samples will be kept for possible further metabolomics and foodomics analyses.

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Acronym: S51

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 21, 2019
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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