- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00951756
Controlled Feeding Experiment (CaFE)
June 22, 2013 updated by: James Lewis
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 >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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: High Fat Low Fiber Diet
|
High fat diet and low fat diet are composed of the same food, but the portion sizes are varied.
|
Other: Low Fat High Fiber Diet
|
High fat diet and low fat diet are composed of the same food, but the portion sizes are varied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
August 3, 2009
First Submitted That Met QC Criteria
August 3, 2009
First Posted (Estimate)
August 4, 2009
Study Record Updates
Last Update Posted (Estimate)
June 25, 2013
Last Update Submitted That Met QC Criteria
June 22, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- DK83981
- UH2DK083981 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Effect of Diet on Microbiome Composition
-
Arkansas Children's Hospital Research InstituteActive, not recruitingEffect of Diet on Breast Milk CompositionUnited States
-
Persephone BiosciencesKroger HealthRecruitingImpact of Dietary Chages Directed by Medical Nutrition Therapy on Gut Microbiome CompositionUnited States
-
University of BolognaCompletedEffect of Different Exercise Programs on Body CompositionItaly
-
University of Sao PauloSuspendedEffect of Chronic Leucine Supplementation on Glucose Homeostasis, Lipid Profile, Body Composition, and Muscle Mass and StrenghtBrazil
-
Arizona State UniversityCompleted
-
Quadram Institute BioscienceNorfolk and Norwich University Hospitals NHS Foundation TrustCompleted
-
University of AlicanteRecruitingCardiovascular Diseases | Body Weight | Body Composition | Diet, Mediterranean | Antioxidant Effect | DensitometrySpain
-
The University of Texas Health Science Center,...Not yet recruitingEffect of Methadone on the Duration on Mechanical VentilationUnited States
-
University of ReadingUnilever R&DNot yet recruitingFocus of Study: 1- Effect of Tea Consumption on Gut Microbiota | Focus of Study: 2- Effect of Tea Consumption on Body-iron StatusUnited Kingdom
-
Cardioangiologisches Centrum BethanienCompletedEffect of NOAC on POCT
Clinical Trials on High fat diet
-
Rutgers, The State University of New JerseyCompleted
-
Maastricht University Medical CenterCompleted
-
Zhejiang UniversityNational Natural Science Foundation of China; Chinese PLA General Hospital; National...Completed
-
University of Alabama at BirminghamSmartFoods, Inc.Completed
-
Laval UniversityRecruiting
-
Tufts UniversityCompletedDyslipidemia | Impaired Glucose Tolerance
-
University Hospital, LilleMinistry of Health, FranceCompletedMitochondrial Cytopathies DisordersFrance
-
Oregon Health and Science UniversityNational Institutes of Health (NIH)Recruiting
-
UCSF Benioff Children's Hospital OaklandNational Cattlemen's Beef AssociationCompletedHealthy | Cardiovascular Disease | Atherogenic DyslipidemiaUnited States
-
Haukeland University HospitalUniversity of BergenCompleted