Status:
COMPLETED
Controlled Feeding Experiment
Lead Sponsor:
James Lewis
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Effect of Diet on Microbiome Composition
Eligibility:
All Genders
18-40 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Participant is capable of giving informed consent
- Participant is age 18 to 40 years
Exclusion
- 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.
- Allergies or intolerance to the components of the study diets.
- 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.
- Any condition that the investigator feels may limit the volunteer's ability to complete the study protocol.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00951756
Start Date
July 1 2009
End Date
August 1 2011
Last Update
June 25 2013
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104