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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Nutritional Intervention Other: high-fat meal A Other: high-fat meal B Other: high-fat meal C Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Identification of Nutritional Health Biomarkers for Metabolic Flexibility in Blood - a Randomized, Postprandial, Caloric Dose-response Strategy
Study Start Date : March 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : November 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: normal weight subjects 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
Experimental: obese subjects 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995110


Locations
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Switzerland
Agroscope
Berne, Switzerland, CH-3003
University Hospital Inselspital Berne
Berne, Switzerland, CH-3010
Sponsors and Collaborators
Agroscope Liebefeld-Posieux Research Station ALP
Investigators
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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
More Information
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Responsible Party: Agroscope Liebefeld-Posieux Research Station ALP
ClinicalTrials.gov Identifier: NCT01995110    
Other Study ID Numbers: NUTRICHIP-1-transcriptome
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: April 24, 2014
Last Verified: April 2014