Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet (Microbiota)

Does the small bowel microbiota in healthy individuals change after consumption of a Western diet?

Study Overview

• Status: Completed
• Conditions: Small Intestine Bacteria
• Intervention / Treatment: Behavioral: Western diet

Detailed Description

The gut microbiota is increasingly being implicated in disease. However, due to difficulty accessing the small bowel (i.e. requiring upper endoscopy) and the relative paucity of bacteria in this area (secondary to luminal flow and bactericidal bile acids/gastric acid), the small bowel microbiota is infrequently evaluated in any studies of this nature. The small bowel microbiota continues to remain an unexplored area of the gastrointestinal tract. Characterization of the microbial community and its function is the first step in determining how it potentially affects health and disease.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults between (and including) 18-65 years old.

• On a baseline healthy diet characterized by:

  • High fiber of ≥ 14 g/1000 calories/day
  • < 10% of daily calories from added sugar
  • At least 5 servings of fruit and vegetables per day
  • < or = 13% of daily calories from saturated fat

Exclusion Criteria:

• Patients who do not meet the above diet requirements.
• Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions.
• Presence of abdominal symptoms based on baseline questionnaire.
• Commercial oral antibiotic or probiotic use within the past 4 weeks.
• Pregnancy or plans to become pregnant within the study time frame
• Vulnerable adults
• Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No western diet; Participants will undergo one-time testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will be finished with testing after the upper endoscopy is complete.
Experimental: Western diet; Participants will undergo a first day of testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will then consume a Western diet for 7 days before a second day of identical testing (blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies).	Behavioral: Western diet; Western diet for 7 days: the meals in this Western diet will be provided by the Clinical Research and Trials Unit (CRTU) after participants meet with the nutrition staff (to discuss food preferences, how to obtain the meals). The meals will reflect a typical Western diet: a low fiber, high sugar diet with weight maintenance calories with < 10 grams fiber per day, and a typical US macronutrient calorie distribution of 50% carbs, 35% fat and 15% protein, with no alcohol. At least 50% of carbohydrates will be provided as simple sugars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcriptional changes in gut microbiota present in stool.	DNA extraction from stool samples will be done using standard assays.	Baseline, approximately three weeks.

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Icahn School of Medicine at Mount Sinai; Imperial College London; University of Minnesota; Colorado State University
• Investigators: Principal Investigator: Purna C Kashyap, M.B.B.S., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2017
• Primary Completion (Actual): May 16, 2017
• Study Completion (Actual): May 19, 2017

Study Registration Dates

• First Submitted: October 26, 2016
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Gut microbiota
• Other Study ID Numbers: 16-006388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Principal investigator will protect the safety of subjects, the validity of data and the integrity of the research by assigning a study identification number to the subject. All information will be kept in a locked file cabinet and all data will be in a password protected computer database. All specimens will be stored in the principal investigator's freezer.