Prestudy: Lifestyle and Cardiovascular Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Norwegian University of Science and Technology
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •healthy males, BMI\>30
Exclusion Criteria
- •known chronic disease or in need of any medical treatment
Outcomes
Primary Outcomes
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.
Time Frame: Four weeks
Secondary Outcomes
- Time to stabilization of gene expression changes due to dietary intervention.(0, 1, 2, 7, 14 and 28 days)