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

April 23, 2014 updated by: Agroscope Liebefeld-Posieux Research Station ALP

Identification of Nutritional Health Biomarkers for Metabolic Flexibility in Blood - a Randomized, Postprandial, Caloric Dose-response Strategy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

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

  • Switzerland
      • Berne, Switzerland, CH-3003
        • Agroscope
      • Berne, Switzerland, CH-3010
        • University Hospital Inselspital Berne

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

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: normal weight subjects
Other: high-fat meal A
Other Names:
  • high-fat meal consisting of 500 kcal
Other: high-fat meal B
Other Names:
  • high-fat meal B consisting of 1000 kcal
Other: high-fat meal C
Other Names:
  • high-fat meal C consisting of 1500 kcal
Experimental: obese subjects
Other: high-fat meal A
Other Names:
  • high-fat meal consisting of 500 kcal
Other: high-fat meal B
Other Names:
  • high-fat meal B consisting of 1000 kcal
Other: high-fat meal C
Other Names:
  • high-fat meal C consisting of 1500 kcal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0h, 2h, 4h, 6h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agroscope Liebefeld-Posieux Research Station ALP

Investigators

  • Study Director: Kurt Laederach, MD, Inselspital University of Berne
  • Principal Investigator: Guy Vergeres, PhD, Agroscope Liebefeld-Posieux Research Station ALP
  • Study Director: Doreen Gille, M.Sc., Agroscope Liebefeld-Posieux Research Station ALP

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

March 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimate)

November 26, 2013

Study Record Updates

Last Update Posted (Estimate)

April 24, 2014

Last Update Submitted That Met QC Criteria

April 23, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • NUTRICHIP-1-transcriptome

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.

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