Prestudy: Lifestyle and Cardiovascular Disease
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|ClinicalTrials.gov Identifier: NCT00592397|
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : January 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity Diabetes Mellitus Cardiovascular Diseases||Other: Balanced macronutrient diet intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Prestudy: Lifestyle and Cardiovascular Disease|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||April 2006|
|Actual Study Completion Date :||April 2006|
All participants underwent the same dietary intervention
Other: Balanced macronutrient diet intervention
Isocaloric dietary changes from typically Western diet to balanced macronutrient composition.
Other Name: Microarray study of diet intervention
- 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 ]
- Time to stabilization of gene expression changes due to dietary intervention. [ Time Frame: 0, 1, 2, 7, 14 and 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592397
|Norwegian University of Science and Technology|
|Trondheim, Mid-Norway, Norway, 7491|
|Principal Investigator:||Berit Johansen, PhD||Norwegian University of Science and Technology|