Prestudy: Lifestyle and Cardiovascular Disease

NCT00592397 | Completed DMC

• 2 other identifiers: REK 4.2005.218713714
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes Mellitus; Cardiovascular Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to stabilization of gene expression changes due to dietary intervention.

  0, 1, 2, 7, 14 and 28 days

Study Arms (1)

1

EXPERIMENTAL

All participants underwent the same dietary intervention

Other: Balanced macronutrient diet intervention

Interventions

Balanced macronutrient diet intervention OTHER

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

Also known as: Microarray study of diet intervention

1

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy males, BMI\>30

You may not qualify if:

• known chronic disease or in need of any medical treatment

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• FUGE Mid-Norway: collaborator

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, Mid-Norway, 7491, Norway

Location

Related 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(1):41-52. doi: 10.1089/omi.2010.0124. Epub 2011 Jun 16.

  PMID: 21679058 RESULT

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Berit Johansen, PhD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 14, 2008
• Study Start: March 1, 2006
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: January 30, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)