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

Cardiovascular Diseases Clinical Trial

— Foodgene  

Official title:

Health Risk Assessment of Dietary Carbohydrates in Chronic Disease Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733018
• Other study ID #: REK 4.2007.515
• Secondary ID: 16649
• Status: Completed
• Phase: N/A
• First received: August 11, 2008
• Last updated: January 27, 2017
• Start date: December 2007
• Est. completion date: July 2009

Study information

• Verified date: January 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• healthy

• BMI 24.5-27.5

• pass health check criteria

Exclusion Criteria:

• chronic diseases

• inflammation

• pregnancy and lactation

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Disease

Intervention

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.

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	FUGE, Mid-Norway, Trondheim, Norway, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in microarray gene expression profiles in blood from healthy young women and men, in response to western or balanced dietary macro nutrient composition.		Before and after each of two 6-days diet intervention periods
Secondary	Inflammatory markers, hormonal dietary responses and blood lipids		Before and after each of two 6-days diet intervention periods