Nutrigenomics Diet Intervention Study Comparing Effects of Western and Balanced Diet in Healthy Subjects (Foodgene)

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:
NCT00733018
First received: August 11, 2008
Last updated: March 25, 2010
Last verified: March 2010

August 11, 2008
March 25, 2010
December 2007
June 2008   (final data collection date for primary outcome measure)
Changes in microarray gene expression profiles in blood from healthy young women and men, in response to western or balanced dietary macro nutrient composition. [ Time Frame: Before and after each of two 6-days diet intervention periods ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00733018 on ClinicalTrials.gov Archive Site
Inflammatory markers, hormonal dietary responses and blood lipids [ Time Frame: Before and after each of two 6-days diet intervention periods ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Nutrigenomics Diet Intervention Study Comparing Effects of Western and Balanced Diet in Healthy Subjects
Health Risk Assessment of Dietary Carbohydrates in Chronic Disease Development

Diet macronutrient relative composition, quality and quantity determines lifestyle disease, including cardiovascular disease, development. Our hypothesis is that a high content of carbohydrates in the diet contributes to increased insulin level. Moreover, activating enzymes promoting inflammatory processes and possibly chronic disease development in the body.

The most frequent cause of death in both women and men in the western world is cardiovascular artery disease (CAD). Well accepted as a lifestyle disease, known risk factors for CAD development include changes in blood lipid content and type as well as micro inflammation in the arterial wall. Low density lipoprotein (LDL) and triglycerides are increased, high density lipoprotein (HDL) is reduced. Furthermore, type II diabetes, metabolic syndrome, hypertension, overweight, reduced physical activity and smoking also precede CAD development. Common for many of the risk factors is that they are induced by improper diet. Recent research has shown that especially total amount, composition and quality of the macro nutrients, protein, carbohydrate and fats, is important. In this project we will explore changes in blood gene expression in response to a western and a balanced crossover diet intervention.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Cardiovascular Diseases
  • Chronic Disease
Behavioral: "Western" versus "balanced" macro nutrient diet composition
Randomized crossover diet intervention. 6 days on solely one of two isocaloric diets, 8 days washout, and then the other diet for 6 days. Fasting blood sampling before and after each diet intervention period.
Other Names:
  • western diet
  • high-carbohydrate, low fat, low protein diet
  • balanced diet
  • low-carbohydrate, high fat, high protein diet
  • Active Comparator: A
    Diet A - Western diet
    Intervention: Behavioral: "Western" versus "balanced" macro nutrient diet composition
  • Active Comparator: B
    Diet B - Balanced diet
    Intervention: Behavioral: "Western" versus "balanced" macro nutrient diet composition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2009
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy
  • BMI 24.5-27.5
  • pass health check criteria

Exclusion Criteria:

  • chronic diseases
  • inflammation
  • pregnancy and lactation
Both
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00733018
REK 4.2007.515, NSD 16649
Yes
Berit Johansen/Professor ; Ingerid Arbo/MSc, Norwegian University of Science and Technology
Norwegian University of Science and Technology
  • St. Olavs Hospital
  • FUGE, Mid-Norway, Trondheim, Norway
Principal Investigator: Berit Johansen, PhD Norwegian University of Sciense and Technology
Study Chair: Ingerid Arbo, MSc Norwegian University of Science and Technology
Norwegian University of Science and Technology
March 2010

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