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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
History of Changes
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Chronic Disease
 Behavioral: "Western" versus "balanced" macro nutrient diet composition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Health Risk Assessment of Dietary Carbohydrates in Chronic Disease Development

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: December 2007
Study Completion Date: July 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Diet A - Western diet
 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: B
Diet B - Balanced diet
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • chronic diseases
  • inflammation
  • pregnancy and lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733018

Locations
Norway
Norwegian University of Science and Technology
Trondheim, Norway, 7491
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
FUGE, Mid-Norway, Trondheim, Norway
Investigators
Principal Investigator: Berit Johansen, PhD Norwegian University of Sciense and Technology
Study Chair: Ingerid Arbo, MSc Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Berit Johansen/Professor ; Ingerid Arbo/MSc, Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00733018     History of Changes
Other Study ID Numbers: REK 4.2007.515, NSD 16649
Study First Received: August 11, 2008
Last Updated: March 25, 2010
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Nutrigenomics
Gene Expression
Diet, Carbohydrate-Restricted
Life Style
Health Behavior

Additional relevant MeSH terms:
Cardiovascular Diseases
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013