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Postprandial Blood Cell Transcriptome of Normal Weight and Obese Subjects to 3 Caloric Doses of a High-fat Meal

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ClinicalTrials.gov Identifier: NCT01995110
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : April 24, 2014
Sponsor:
Information provided by (Responsible Party):
Agroscope Liebefeld-Posieux Research Station ALP

Tracking Information
First Submitted Date  ICMJE November 21, 2013
First Posted Date  ICMJE November 26, 2013
Last Update Posted Date April 24, 2014
Study Start Date  ICMJE March 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
blood cell transkriptome/ gene-expression [ Time Frame: 0h, 2h, 4h, 6h ]
  • differently expressed genes between normal weight and obese subjects at baseline
  • changes in gene-expression 2, 4 and 6h after consumption
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postprandial Blood Cell Transcriptome of Normal Weight and Obese Subjects to 3 Caloric Doses of a High-fat Meal
Official Title  ICMJE Identification of Nutritional Health Biomarkers for Metabolic Flexibility in Blood - a Randomized, Postprandial, Caloric Dose-response Strategy
Brief Summary The study will quantitatively evaluate the metabolic response of normal weight and obese subjects to three high-fat meals differing in caloric dose by analysing the postprandial blood transcriptome.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Obesity
  • Nutritional Intervention
Intervention  ICMJE
  • Other: high-fat meal A
    Other Name: high-fat meal consisting of 500 kcal
  • Other: high-fat meal B
    Other Name: high-fat meal B consisting of 1000 kcal
  • Other: high-fat meal C
    Other Name: high-fat meal C consisting of 1500 kcal
Study Arms  ICMJE
  • Experimental: normal weight subjects
    Interventions:
    • Other: high-fat meal A
    • Other: high-fat meal B
    • Other: high-fat meal C
  • Experimental: obese subjects
    Interventions:
    • Other: high-fat meal A
    • Other: high-fat meal B
    • Other: high-fat meal C
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2013)
14
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for normal weight subjects:

  • age 25-50
  • 20<BMI>25
  • waist circumference <94cm

Inclusion Criteria for obese subjects:

  • age 25-50
  • 30<BMI>40
  • waist circumference >102cm

Exclusion Criteria for both groups:

  • physiological or psychological diseases
  • allergies to food or intolerance to high-fat meal
  • vegetarians, vegans
  • chronic intake of drugs
  • smokers
  • diabetes mellitus type I and II
  • debiliating kidney disease
  • debiliating liver disease
  • clinically established coronary heart diseases
  • ingestion of vitamins or dietary supplements during the course of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 25 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01995110
Other Study ID Numbers  ICMJE NUTRICHIP-1-transcriptome
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Agroscope Liebefeld-Posieux Research Station ALP
Study Sponsor  ICMJE Agroscope Liebefeld-Posieux Research Station ALP
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guy Vergeres, PhD Agroscope Liebefeld-Posieux Research Station ALP
Study Director: Doreen Gille, M.Sc. Agroscope Liebefeld-Posieux Research Station ALP
Study Director: Kurt Laederach, MD Inselspital University of Berne
PRS Account Agroscope Liebefeld-Posieux Research Station ALP
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP