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| Sponsors and Collaborators: |
Norwegian University of Science and Technology St. Olavs Hospital FUGE, Mid-Norway, Trondheim, Norway |
|---|---|
| Information provided by: | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT00592397 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Nutrigenomics Diet, Carbohydrate-Restricted Life Style Health Behavior Obesity |
Other: Balanced macronutrient diet intervention |
| Study Type: | Interventional |
| Study Design: | Basic Science, Open Label, Single Group Assignment |
| Official Title: | Prestudy: Lifestyle and Cardiovascular Disease |
| Enrollment: | 5 |
| Study Start Date: | March 2006 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
All participants underwent the same dietary intervention
|
Other: Balanced macronutrient diet intervention
Isocaloric dietary changes from typically Western diet to balanced macronutrient composition.
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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.
Eligibility| Ages Eligible for Study: | 30 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Norway, Mid-Norway | |
| Norwegian University of Science and Technology | |
| Trondheim, Mid-Norway, Norway, 7491 | |
| Principal Investigator: | Berit Johansen, Dr Philos | Norwegian University of Science and Technology |
More Information
| Responsible Party: | Norwegian University of Science and Technology ( Berit Johansen/Professor ) |
| Study ID Numbers: | REK 4.2005.2187, REK 4.2005.2187, NSD 13714 |
| Study First Received: | January 2, 2008 |
| Last Updated: | January 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00592397 History of Changes |
| Health Authority: | Norway: Norwegian Social Science Data Services |
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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 |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
|
Body Weight Signs and Symptoms Obesity Nutrition Disorders |
Overweight Overnutrition Cardiovascular Diseases |
