We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prestudy: Lifestyle and Cardiovascular Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00592397
First Posted: January 14, 2008
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
St. Olavs Hospital
FUGE, Mid-Norway, Trondheim, Norway
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  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
Obesity Diabetes Mellitus Cardiovascular Diseases Other: Balanced macronutrient diet intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Prestudy: Lifestyle and Cardiovascular Disease

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 ]

Secondary Outcome Measures:
  • Time to stabilization of gene expression changes due to dietary intervention. [ Time Frame: 0, 1, 2, 7, 14 and 28 days ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

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


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, PhD Norwegian University of Science and Technology
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00592397     History of Changes
Other Study ID Numbers: REK 4.2005.2187
13714 ( Other Identifier: NSD )
First Submitted: January 2, 2008
First Posted: January 14, 2008
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Diabetes Mellitus
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases