Controlled Feeding Experiment

NCT ID: NCT00951756

Last Updated: 2013-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-08-31

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.

Conditions

Effect of Diet on Microbiome Composition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

High Fat Low Fiber Diet

Group Type: OTHER

High fat diet

Intervention Type: OTHER

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

Low Fat High Fiber Diet

Group Type: OTHER

High fat diet

Intervention Type: OTHER

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

Interventions

High fat diet

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Participant is capable of giving informed consent

2. Participant is age 18 to 40 years

Exclusion Criteria

1. Diagnosis with Inflammatory bowel disease (IBD), celiac disease, or other chronic intestinal disorders.

2. Baseline bowel frequency less than every 2 days or greater than 3 times daily.

3. Current smoker.

4. Body Mass Index (BMI) <18.5 of >35.

5. Diabetes mellitus (DM)

6. Diagnosis with coronary artery disease, congestive heart failure, or prior myocardial infarction.

7. 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.

8. Prior bowel resection surgery.

9. 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.

10. Student or employee of any one of the investigators.

11. Pregnant women.

12. Use of antibiotics in the prior 6 months.

13. Use of antacids, non-steroidal anti-inflammatory drugs (NSAIDs), or dietary supplements in the preceding 2 weeks.

14. 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.

15. HIV infection, AIDS, or other known conditions resulting in immunosuppression.

16. Allergies or intolerance to the components of the study diets.

17. Participant has experienced diarrhea within the two weeks prior to the first sigmoidoscopy. Diarrhea is defined as a change in bowel habits with an increased frequency or loose stools such that the stool could not be lifted with a fork.

18. Any condition that the investigator feels may limit the volunteer's ability to complete the study protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

James Lewis

OTHER

Sponsor Role: lead

Responsible Party

James Lewis

Professor of Medicine and Epidemiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

James D Lewis, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UH2DK083981

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK83981

Identifier Type: -

Identifier Source: org_study_id