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Prestudy: Lifestyle and Cardiovascular Disease

This study has been completed.
Sponsor:
Collaborators:
St. Olavs Hospital
FUGE, Mid-Norway, Trondheim, Norway
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00592397
First received: January 2, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted

January 2, 2008
January 2, 2008
March 2006
April 2006   (final data collection date for primary outcome measure)
Changes in microarray gene expression profiles in blood and subcutaneous abdominal fat tissue from healthy obese men, as a consequence of changes in dietary macro nutrient composition. [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Time to stabilization of gene expression changes due to dietary intervention. [ Time Frame: 0, 1, 2, 7, 14 and 28 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prestudy: Lifestyle and Cardiovascular Disease
Prestudy: Lifestyle and Cardiovascular Disease

The purpose of this pilot study is to optimize conditions for a planned human intervention study focusing on how diet predispose for, and influence, lifestyle disease development and its consequence in cardiovascular disease development.

Common for many of the risk factors of lifestyle diseases is that they are induced by improper diet. Recent research has shown that especially total amount and composition of the macro nutrients, protein, carbohydrate and fats, is important.

A time course experiment has been performed where 5 subjects underwent a diet intervention for four weeks with a controlled, balanced macro nutrient energy content of every meal. The sampling time points were 0, 1, 2, 7, 14 and 28 days. The goals were to determine optimal length of intervention with stabilization of gene expression to occur and compare blood and subcutaneous abdominal fat tissue as source of biological material for RNA for DNA microarray analysis. Microarray analysis were performed on 3 of the 5 subjects.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Nutrigenomics
  • Diet, Carbohydrate-Restricted
  • Life Style
  • Health Behavior
  • Obesity
Other: Balanced macronutrient diet intervention
Isocaloric dietary changes from typically Western diet to balanced macronutrient composition.
Other Name: Microarray study of diet intervention
Experimental: 1
All participants underwent the same dietary intervention
Intervention: Other: Balanced macronutrient diet intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
April 2006
April 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy males, BMI>30

Exclusion Criteria:

  • known chronic disease or in need of any medical treatment
Male
30 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00592397
REK 4.2005.2187, REK 4.2005.2187, NSD 13714
Yes
Berit Johansen/Professor, Norwegian University of Science and Technology
Norwegian University of Science and Technology
  • St. Olavs Hospital
  • FUGE, Mid-Norway, Trondheim, Norway
Principal Investigator: Berit Johansen, Dr Philos Norwegian University of Science and Technology
Norwegian University of Science and Technology
January 2008

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