Prestudy: Lifestyle and Cardiovascular Disease

Study Overview
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Brief Summary
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The purpose of this pilot study is to optimize conditions for a planned human intervention study focusing on how diet predispose for, and influence, lifestyle disease development and its consequence in cardiovascular disease development.

Detailed Description
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Common for many of the risk factors of lifestyle diseases is that they are induced by improper diet. Recent research has shown that especially total amount and composition of the macro nutrients, protein, carbohydrate and fats, is important. A time course experiment has been performed where 5 subjects underwent a diet intervention for four weeks with a controlled, balanced macro nutrient energy content of every meal. The sampling time points were 0, 1, 2, 7, 14 and 28 days. The goals were to determine optimal length of intervention with stabilization of gene expression to occur and compare blood and subcutaneous abdominal fat tissue as source of biological material for RNA for DNA microarray analysis. Microarray analysis were performed on 3 of the 5 subjects.

Official Title
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Prestudy: Lifestyle and Cardiovascular Disease

Conditions
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Obesity, Diabetes Mellitus, Cardiovascular Diseases

Intervention / Treatment
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* Other: Balanced macronutrient diet intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy males, BMI>30 Exclusion Criteria: known chronic disease or in need of any medical treatment

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>All participants underwent the same dietary intervention | Other: Balanced macronutrient diet intervention<br>* Isocaloric dietary changes from typically Western diet to balanced macronutrient composition.<br>* Other names: Microarray study of diet intervention;|

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 and subcutaneous abdominal fat tissue from healthy obese men, as a consequence of changes in dietary macro nutrient composition. |  | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to stabilization of gene expression changes due to dietary intervention. |  | 0, 1, 2, 7, 14 and 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary Intervention, Nutrigenomics, Diet, Carbohydrate-Restricted, Gene Expression, Gene Expression Profiling, Oligonucleotide Array Sequence Analysis, Biological Markers, Food, Obesity, Blood, Subcutaneous Fat, Abdominal