Prestudy: Lifestyle and Cardiovascular Disease

Not Applicable

Completed

• Conditions: Obesity; Diabetes Mellitus; Cardiovascular Diseases
• Interventions: Other: Balanced macronutrient diet intervention

• Registration Number: NCT00592397
• Lead Sponsor: Norwegian University of Science and Technology

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.

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2008-01-02
• Study First Submitted QC: 2008-01-02
• Study First Posted: 2008-01-14
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 5

Inclusion Criteria

• healthy males, BMI>30

Exclusion Criteria

• known chronic disease or in need of any medical treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Balanced macronutrient diet intervention	All participants underwent the same dietary intervention

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Norwegian University of Science and Technology; 🇳🇴 Trondheim, Mid-Norway, Norway