Nutrigenomics Diet Intervention Study Comparing Effects of Western and Balanced Diet in Healthy Subjects - Full Text View

Sponsors and Collaborators:	Norwegian University of Science and Technology St. Olavs Hospital FUGE, Mid-Norway, Trondheim, Norway
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00733018

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:	Basic Science, Randomized, Open Label, Crossover Assignment, Efficacy Study
Official Title:	Health Risk Assessment of Dietary Carbohydrates in Chronic Disease Development

Resource links provided by NLM:

MedlinePlus related topics: Carbohydrates Coping with Chronic Illness Diets

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
Estimated Study Completion Date:	July 2009
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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.
B: Active Comparator 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.

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:	Norwegian University of Science and Technology ( Berit Johansen/Professor ; Ingerid Arbo/MSc )
Study ID Numbers:	REK 4.2007.515, NSD 16649
Study First Received:	August 11, 2008
Last Updated:	February 16, 2009
ClinicalTrials.gov Identifier:	NCT00733018 History of Changes
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

Study placed in the following topic categories:

Chronic Disease
Healthy

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Chronic Disease
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2009