Controlled Feeding Experiment of High and Low Fat Diet and Stool Microbiome Controlled Feeding Experiment of High and Low Fat Diet and Stool Microbiome Composition

James Lewis1 site in 1 country10 target enrollmentJuly 2009

ConditionsEffect of Diet on Microbiome Composition

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Effect of Diet on Microbiome Composition
Sponsor: James Lewis
Enrollment: 10
Locations: 1
Primary Endpoint: This is not an efficacy study. There is no pre-specified clinical endpoint for this study. Rather, the outcome is the composition of the gut microbiome.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the effect of dietary fat, in standard formulation, on the composition of the human microbiome in a prospective study of normal volunteers. Participants will be randomly assigned to either a high fat or low fat diet for 10 days. The gut microbiome will be phylotyped in fecal samples as well as in bacteria adherent to the colonic mucosa prior to, and during the course of the dietary interventions.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

August 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

James Lewis

Responsible Party

Sponsor Investigator

Principal Investigator

James Lewis

Professor of Medicine and Epidemiology

University of Pennsylvania

Eligibility Criteria

Inclusion Criteria

•Participant is capable of giving informed consent
•Participant is age 18 to 40 years

Exclusion Criteria

•Diagnosis with Inflammatory bowel disease (IBD), celiac disease, or other chronic intestinal disorders.
•Baseline bowel frequency less than every 2 days or greater than 3 times daily.
•Current smoker.
•Body Mass Index (BMI) \<18.5 of \>
•Diabetes mellitus (DM)
•Diagnosis with coronary artery disease, congestive heart failure, or prior myocardial infarction.
•History of dyslipidemia or receiving treatment for hypercholesterolemia. This will be defined as a fasting LDL \>160 mg/dL or a non-fasting total cholesterol \>200 mg/dL or non-fasting HDL\<40 mg/dl. Additionally, patients receiving drug therapy for hypercholesterolemia will be excluded.
•Prior bowel resection surgery.
•Contraindication to flexible sigmoidoscopy and biopsies. Patients with suppressed white blood count may be at increased risk of systemic infection following sigmoidoscopy with biopsies. As such, subjects with a white blood cell (WBC) count less than 3,500 or an absolute neutrophil count of less than 1,000 will be excluded. Patients with thrombocytopenia or with a coagulopathy may be at increased risk of bleeding complications after colonoscopic biopsies. As such, patients with a platelet count of less than 100,000 or an international normalized ratio (INR) greater than 1.2 will be excluded from the study.
•Student or employee of any one of the investigators.

Outcomes

Primary Outcomes

This is not an efficacy study. There is no pre-specified clinical endpoint for this study. Rather, the outcome is the composition of the gut microbiome.

Time Frame: 10 days