Clinical trial NCT00733018: Nutrigenomics Diet Intervention Study Comparing Effects of Western and Balanced Diet in Healthy Subjects
Official title: Health Risk Assessment of Dietary Carbohydrates in Chronic Disease Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Chronic Disease
Keywords: Nutrigenomics
Gene Expression
Diet, Carbohydrate-Restricted
Life Style
Health Behavior
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: FUGE Mid-Norway
First posted: 2008-08-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* chronic diseases
* inflammation
* pregnancy and lactation

Primary outcomes:
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.
timeFrame: Before and after each of two 6-days diet intervention periods
Secondary outcomes:
measure: Inflammatory markers, hormonal dietary responses and blood lipids
timeFrame: Before and after each of two 6-days diet intervention periods
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Sciense and Technology
name: Berit Johansen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.