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

NCT03266536 | Completed

• 1 other identifier: 16-006388
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Small Intestine Bacteria

Keywords

Gut microbiota

Outcome Measures

Primary Outcomes (1)

• Transcriptional changes in gut microbiota present in stool.

  DNA extraction from stool samples will be done using standard assays.

  Baseline, approximately three weeks.

Study Arms (2)

No western diet

NO INTERVENTION

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.

Western diet

EXPERIMENTAL

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

Interventions

Western diet 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.

Western diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• Colorado State University: collaborator
• University of Minnesota: collaborator
• Imperial College London: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Diet, Western

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Purna C Kashyap, M.B.B.S.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: August 30, 2017
• Study Start: January 9, 2017
• Primary Completion: May 16, 2017
• Study Completion: May 19, 2017
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)