Prestudy: Lifestyle and Cardiovascular Disease

Norwegian University of Science and Technology

Status: Completed

Conditions: Diabetes Mellitus; Obesity; Cardiovascular Diseases

Treatments: Other: Balanced macronutrient diet intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00592397

13714 (Other Identifier)

REK 4.2005.2187

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy males, BMI>30

Exclusion criteria

• known chronic disease or in need of any medical treatment

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

1

Experimental group

Description:

All participants underwent the same dietary intervention

Treatment:

Other: Balanced macronutrient diet intervention