Nutrigenomics Diet Intervention Study Comparing Effects of Western and Balanced Diet in Healthy Subjects

NCT ID: NCT00733018

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-07-31

Brief Summary

Diet macronutrient relative composition, quality and quantity determines lifestyle disease, including cardiovascular disease, development. Our hypothesis is that a high content of carbohydrates in the diet contributes to increased insulin level. Moreover, activating enzymes promoting inflammatory processes and possibly chronic disease development in the body.

Detailed Description

The most frequent cause of death in both women and men in the western world is cardiovascular artery disease (CAD). Well accepted as a lifestyle disease, known risk factors for CAD development include changes in blood lipid content and type as well as micro inflammation in the arterial wall. Low density lipoprotein (LDL) and triglycerides are increased, high density lipoprotein (HDL) is reduced. Furthermore, type II diabetes, metabolic syndrome, hypertension, overweight, reduced physical activity and smoking also precede CAD development. Common for many of the risk factors is that they are induced by improper diet. Recent research has shown that especially total amount, composition and quality of the macro nutrients, protein, carbohydrate and fats, is important. In this project we will explore changes in blood gene expression in response to a western and a balanced crossover diet intervention.

Conditions

Cardiovascular Diseases; Chronic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

A

Diet A - Western diet

Group Type: ACTIVE_COMPARATOR

"Western" versus "balanced" macro nutrient diet composition

Intervention Type: BEHAVIORAL

Randomized crossover diet intervention. 6 days on solely one of two isocaloric diets, 8 days washout, and then the other diet for 6 days. Fasting blood sampling before and after each diet intervention period.

B

Diet B - Balanced diet

Group Type: ACTIVE_COMPARATOR

"Western" versus "balanced" macro nutrient diet composition

Intervention Type: BEHAVIORAL

Randomized crossover diet intervention. 6 days on solely one of two isocaloric diets, 8 days washout, and then the other diet for 6 days. Fasting blood sampling before and after each diet intervention period.

Interventions

"Western" versus "balanced" macro nutrient diet composition

Randomized crossover diet intervention. 6 days on solely one of two isocaloric diets, 8 days washout, and then the other diet for 6 days. Fasting blood sampling before and after each diet intervention period.

Intervention Type: BEHAVIORAL

Other Intervention Names

western diet; high-carbohydrate, low fat, low protein diet; balanced diet; low-carbohydrate, high fat, high protein diet

Eligibility Criteria

Inclusion Criteria

• healthy
• BMI 24.5-27.5
• pass health check criteria

Exclusion Criteria

• chronic diseases
• inflammation
• pregnancy and lactation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

FUGE Mid-Norway

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Berit Johansen, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Sciense and Technology

Locations

Norwegian University of Science and Technology

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: BACKGROUND

PMID: 21679058 (View on PubMed)

Other Identifiers

16649

Identifier Type: OTHER

Identifier Source: secondary_id

REK 4.2007.515

Identifier Type: -

Identifier Source: org_study_id