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

Diet Modification Clinical Trial

— S51  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885544
• Other study ID #: 1709019738
• Status: Completed
• Phase: N/A
• Start date: January 9, 2018
• Est. completion date: March 23, 2020

Study information

• Verified date: July 2020
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 23, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet Modification

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	metabolomics analysis	Saves of blood, urine, and stool samples will be kept for possible further metabolomics and foodomics analyses.	Undecided.
Primary	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.
Primary	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.