Prestudy: Lifestyle and Cardiovascular Disease
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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: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Prestudy: Lifestyle and Cardiovascular Disease |
- 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 ] [ Designated as safety issue: No ]
- Time to stabilization of gene expression changes due to dietary intervention. [ Time Frame: 0, 1, 2, 7, 14 and 28 days ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 1
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
|
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.
Eligibility| Ages Eligible for Study: | 30 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy males, BMI>30
Exclusion Criteria:
- known chronic disease or in need of any medical treatment
Contacts and Locations| 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
No publications provided
| Responsible Party: | Berit Johansen/Professor, Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT00592397 History of Changes |
| Other Study ID Numbers: | REK 4.2005.2187, REK 4.2005.2187, NSD 13714 |
| Study First Received: | January 2, 2008 |
| Last Updated: | January 2, 2008 |
| Health Authority: | Norway: Norwegian Social Science Data Services |
Keywords provided by Norwegian University of Science and Technology:
|
Dietary Intervention Nutrigenomics Diet, Carbohydrate-Restricted Gene Expression Gene Expression Profiling Oligonucleotide Array Sequence Analysis |
Biological Markers Food Obesity Blood Subcutaneous Fat, Abdominal |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013