Prestudy: Lifestyle and Cardiovascular Disease - Full Text View

Sponsor:	Norwegian University of Science and Technology
Collaborators:	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:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Prestudy: Lifestyle and Cardiovascular Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Healthy Living Obesity

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Criteria

Inclusion Criteria:

healthy males, BMI>30

Exclusion Criteria:

known chronic disease or in need of any medical treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592397

Locations

Norway
Norwegian University of Science and Technology
Trondheim, Mid-Norway, Norway, 7491

Sponsors and Collaborators

Norwegian University of Science and Technology

St. Olavs Hospital

FUGE, Mid-Norway, Trondheim, Norway

Investigators

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 22, 2012