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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Chronic Disease
• Interventions: Behavioral: "Western" versus "balanced" macro nutrient diet composition

• Registration Number: NCT00733018
• Lead Sponsor: Norwegian University of Science and Technology

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.

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-06
• Study First Submitted: 2008-08-11
• Study First Submitted QC: 2008-08-11
• Study First Posted: 2008-08-12
• Study Completion: 2009-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• chronic diseases
• inflammation
• pregnancy and lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	"Western" versus "balanced" macro nutrient diet composition	Diet A - Western diet
B	"Western" versus "balanced" macro nutrient diet composition	Diet B - Balanced diet

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Inflammatory markers, hormonal dietary responses and blood lipids	Before and after each of two 6-days diet intervention periods

Trial Locations

Locations (1)

Norwegian University of Science and Technology; 🇳🇴 Trondheim, Norway