Skip to main content
OpenTrials
Completed

NCT Number: NCT00733018

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Diseases Behavior Chronic Disease Disease Attributes Health Behavior Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian University of Science and Technology

Trondheim, 7491, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • chronic diseases
  • inflammation
  • pregnancy and lactation

Treatment and study plan

"Western" versus "balanced" macro nutrient diet composition

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Inflammatory markers, hormonal dietary responses and blood lipids

    Time frame: Before and after each of two 6-days diet intervention periods

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • FUGE Mid-Norway
  • St. Olavs Hospital

Registry information

Official study title

Health Risk Assessment of Dietary Carbohydrates in Chronic Disease Development

Acronym: Foodgene

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Aug 12, 2008
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.