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CompletedNCT00951756CaFEUpdated Jun 25, 2013

Controlled Feeding Experiment

An interventional study of High fat diet in Effect of Diet on Microbiome Composition, sponsored by James Lewis. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-25.

Sponsored by James Lewis · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Effect of Diet on Microbiome Composition

Keywords

  • Dietary fat
  • Microbiome composition
  • Controlled feeding experiment
03

In context

Lead sponsor

James Lewis is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Participant is capable of giving informed consent
  2. Participant is age 18 to 40 years

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Other
    High Fat Low Fiber Diet

    Other: High fat diet

  • Other
    Low Fat High Fiber Diet

    Other: High fat diet

Interventions

  • OtherHigh fat diet

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

06

What researchers measure

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.

    Time frame: 10 days

07

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00951756
Lead sponsor
James Lewis
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
James Lewis (Professor of Medicine and Epidemiology, University of Pennsylvania) — Sponsor-investigator
First posted
Aug 4, 2009
Start date
Jul 2009
Primary completion
Jan 2010
Completion
Aug 2011
Last update
Jun 25, 2013

Study contacts

James D Lewis, MD, MSCE
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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