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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Health Risk Assessment of Dietary Carbohydrates in Chronic Disease Development

Conditions
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Cardiovascular Diseases, Chronic Disease

Intervention / Treatment
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* Behavioral: Western versus balanced macro nutrient diet composition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy BMI 24.5-27.5 pass health check criteria Exclusion Criteria: chronic diseases inflammation pregnancy and lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Diet A - Western diet | Behavioral: Western versus balanced macro nutrient diet composition<br>* 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.<br>* Other names: low-carbohydrate, high fat, high protein diet;|
| Active Comparator: B<br>Diet B - Balanced diet | Behavioral: Western versus balanced macro nutrient diet composition<br>* 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.<br>* Other names: low-carbohydrate, high fat, high protein diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers, hormonal dietary responses and blood lipids |  | Before and after each of two 6-days diet intervention periods | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrigenomics, Gene Expression, Diet, Carbohydrate-Restricted, Life Style, Health Behavior