Clinical trial NCT03885544: Effects of Consuming Red Meat on the Gut Microbiota in Young Adults
Official title: Effects of Consuming Red Meat on the Gut Microbiota in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Keywords: beef
pork
red meat
gut microbiota
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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).
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Changes in gut microbiota composition
timeFrame: 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.
measure: Concentrations of short chain fatty acids (SCFA)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
measure: metabolomics analysis
timeFrame: Undecided.
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne W Campbell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: