NCT00951756

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

6 months

First QC Date

August 3, 2009

Last Update Submit

June 22, 2013

Conditions

Effect of Diet on Microbiome Composition

Keywords

Dietary fatMicrobiome compositionControlled feeding experiment

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 days

Study Arms (2)

High Fat Low Fiber Diet

OTHER
Other: High fat diet

Low Fat High Fiber Diet

OTHER
Other: High fat diet

Interventions

High fat dietOTHER

High fat diet and low fat diet are composed of the same food, but the portion sizes are varied.

High Fat Low Fiber DietLow Fat High Fiber Diet

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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 \>35.
  • 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.
  • Pregnant women.
  • Use of antibiotics in the prior 6 months.
  • Use of antacids, non-steroidal anti-inflammatory drugs (NSAIDs), or dietary supplements in the preceding 2 weeks.
  • Use of any of the following medications in the 4 weeks prior to randomization: proton pump inhibitors (PPI), histamine receptor antagonists, narcotics, tricyclic antidepressants, anticholinergics (e.g., hyoscamine), metoclopramide, anti-diarrhea medications, laxatives.
  • HIV infection, AIDS, or other known conditions resulting in immunosuppression.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Diet, High-Fat

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • James D Lewis, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine and Epidemiology

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 4, 2009

Study Start

July 1, 2009

Primary Completion

January 1, 2010

Study Completion

August 1, 2011

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations

US(1)