Postprandial Blood Cell Transcriptome of Normal Weight and Obese Subjects to 3 Caloric Doses of a High-fat Meal
Identification of Nutritional Health Biomarkers for Metabolic Flexibility in Blood - a Randomized, Postprandial, Caloric Dose-response Strategy
1 other identifier
interventional
14
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Mar 2011
Typical duration for not_applicable obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 21, 2013
CompletedFirst Posted
Study publicly available on registry
November 26, 2013
CompletedApril 24, 2014
April 1, 2014
1.4 years
November 21, 2013
April 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
blood cell transkriptome/ gene-expression
* 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
Study Arms (2)
normal weight subjects
EXPERIMENTALobese subjects
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- age 25-50
- \<BMI\>25
- waist circumference \<94cm
- age 25-50
- \<BMI\>40
- waist circumference \>102cm
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Agroscope
Bern, Canton of Bern, CH-3003, Switzerland
University Hospital Inselspital Berne
Bern, Canton of Bern, CH-3010, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2013
First Posted
November 26, 2013
Study Start
March 1, 2011
Primary Completion
August 1, 2012
Study Completion
November 1, 2013
Last Updated
April 24, 2014
Record last verified: 2014-04