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

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ClinicalTrials.gov Identifier: NCT00733018
Recruitment Status : Completed
First Posted : August 12, 2008
Last Update Posted : January 30, 2017
Sponsor:
Collaborators:
St. Olavs Hospital
FUGE Mid-Norway
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE August 11, 2008
First Posted Date  ICMJE August 12, 2008
Last Update Posted Date January 30, 2017
Study Start Date  ICMJE December 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2008)
Inflammatory markers, hormonal dietary responses and blood lipids [ Time Frame: Before and after each of two 6-days diet intervention periods ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutrigenomics Diet Intervention Study Comparing Effects of Western and Balanced Diet in Healthy Subjects
Official Title  ICMJE Health Risk Assessment of Dietary Carbohydrates in Chronic Disease Development
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Cardiovascular Diseases
  • Chronic Disease
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
Publications * Brattbakk HR, Arbo I, Aagaard S, Lindseth I, de Soysa AK, Langaas M, Kulseng B, Lindberg F, Johansen B. Balanced caloric macronutrient composition downregulates immunological gene expression in human blood cells-adipose tissue diverges. OMICS. 2013 Jan;17(1):41-52. doi: 10.1089/omi.2010.0124. Epub 2011 Jun 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • chronic diseases
  • inflammation
  • pregnancy and lactation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00733018
Other Study ID Numbers  ICMJE REK 4.2007.515
16649 ( Other Identifier: NSD )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE
  • St. Olavs Hospital
  • FUGE Mid-Norway
Investigators  ICMJE
Principal Investigator: Berit Johansen, PhD Norwegian University of Sciense and Technology
PRS Account Norwegian University of Science and Technology
Verification Date January 2017

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