Prestudy: Lifestyle and Cardiovascular Disease

Obesity Clinical Trial

Official title:

Prestudy: Lifestyle and Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592397
• Other study ID #: REK 4.2005.2187
• Secondary ID: 13714
• Status: Completed
• Phase: N/A
• First received: January 2, 2008
• Last updated: January 27, 2017
• Start date: March 2006
• Est. completion date: April 2006

Study information

• Verified date: January 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• healthy males, BMI>30

Exclusion Criteria:

• known chronic disease or in need of any medical treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Obesity

Intervention

Other:
• Balanced macronutrient diet intervention
Isocaloric dietary changes from typically Western diet to balanced macronutrient composition.

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim	Mid-Norway

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	FUGE, Mid-Norway, Trondheim, Norway, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Brattbakk HR, Arbo I, Aagaard S, Lindseth I, de Soysa AK, Langaas M, Kulseng B, Lindberg F, Johansen B. Balanced caloric macronutrient composition downregulates immunological gene expression in human blood cells-adipose tissue diverges. OMICS. 2013 Jan;17 — View Citation

Outcome

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