Skip to main content
OpenTrials
Completed

NCT Number: NCT03266536

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Transcriptional changes in gut microbiota present in stool.

    Time frame: Baseline, approximately three weeks.

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Colorado State University
  • Icahn School of Medicine at Mount Sinai
  • Imperial College London
  • University of Minnesota

Registry information

Acronym: Microbiota

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 30, 2017
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.