Prestudy: Lifestyle and Cardiovascular Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00592397

Enrollment

Registered

2008-01-14

Start date

2006-03-31

Completion date

2006-04-30

Last updated

2017-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Diabetes Mellitus, Obesity

Keywords

Dietary Intervention, Nutrigenomics, Diet, Carbohydrate-Restricted, Gene Expression, Gene Expression Profiling, Oligonucleotide Array Sequence Analysis, Biological Markers, Food, Obesity, Blood, Subcutaneous Fat, Abdominal

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.

Interventions

OTHERBalanced macronutrient diet intervention

Isocaloric dietary changes from typically Western diet to balanced macronutrient composition.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

30 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy males, BMI\>30

Exclusion criteria

* known chronic disease or in need of any medical treatment

Design outcomes

Primary

Measure	Time frame
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.	Four weeks

Secondary

Measure	Time frame
Time to stabilization of gene expression changes due to dietary intervention.	0, 1, 2, 7, 14 and 28 days

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026