- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00951756
Controlled Feeding Experiment (CaFE)
22. juni 2013 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
10
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 40 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: High Fat Low Fiber Diet
|
High fat diet and low fat diet are composed of the same food, but the portion sizes are varied.
|
|
Andet: Low Fat High Fiber Diet
|
High fat diet and low fat diet are composed of the same food, but the portion sizes are varied.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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.
Tidsramme: 10 days
|
10 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2009
Primær færdiggørelse (Faktiske)
1. januar 2010
Studieafslutning (Faktiske)
1. august 2011
Datoer for studieregistrering
Først indsendt
3. august 2009
Først indsendt, der opfyldte QC-kriterier
3. august 2009
Først opslået (Skøn)
4. august 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. juni 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juni 2013
Sidst verificeret
1. juni 2013
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- DK83981
- UH2DK083981 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .