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

NCT ID: NCT03266536

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-09
• Study Completion Date: 2017-05-19

Brief Summary

Does the small bowel microbiota in healthy individuals change after consumption of a 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.

Conditions

Small Intestine Bacteria

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

Western diet

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Colorado State University

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Purna C. Kashyap, MBBS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Purna C Kashyap, M.B.B.S.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

16-006388

Identifier Type: -

Identifier Source: org_study_id