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

Primary Purpose

Cardiovascular Diseases, Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
"Western" versus "balanced" macro nutrient diet composition
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiovascular Diseases focused on measuring Nutrigenomics, Gene Expression, Diet, Carbohydrate-Restricted, Life Style, Health Behavior

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • chronic diseases
  • inflammation
  • pregnancy and lactation

Sites / Locations

  • Norwegian University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Diet A - Western diet

Diet B - Balanced diet

Outcomes

Primary Outcome Measures

Changes in microarray gene expression profiles in blood from healthy young women and men, in response to western or balanced dietary macro nutrient composition.

Secondary Outcome Measures

Inflammatory markers, hormonal dietary responses and blood lipids

Full Information

First Posted
August 11, 2008
Last Updated
January 27, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, FUGE Mid-Norway
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1. Study Identification

Unique Protocol Identification Number
NCT00733018
Brief Title
Nutrigenomics Diet Intervention Study Comparing Effects of Western and Balanced Diet in Healthy Subjects
Acronym
Foodgene
Official Title
Health Risk Assessment of Dietary Carbohydrates in Chronic Disease Development
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, FUGE Mid-Norway

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Chronic Disease
Keywords
Nutrigenomics, Gene Expression, Diet, Carbohydrate-Restricted, Life Style, Health Behavior

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Diet A - Western diet
Arm Title
B
Arm Type
Active Comparator
Arm Description
Diet B - Balanced diet
Intervention Type
Behavioral
Intervention Name(s)
"Western" versus "balanced" macro nutrient diet composition
Other Intervention Name(s)
western diet, high-carbohydrate, low fat, low protein diet, balanced diet, low-carbohydrate, high fat, high protein diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in microarray gene expression profiles in blood from healthy young women and men, in response to western or balanced dietary macro nutrient composition.
Time Frame
Before and after each of two 6-days diet intervention periods
Secondary Outcome Measure Information:
Title
Inflammatory markers, hormonal dietary responses and blood lipids
Time Frame
Before and after each of two 6-days diet intervention periods

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy BMI 24.5-27.5 pass health check criteria Exclusion Criteria: chronic diseases inflammation pregnancy and lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berit Johansen, PhD
Organizational Affiliation
Norwegian University of Sciense and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian University of Science and Technology
City
Trondheim
ZIP/Postal Code
7491
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
21679058
Citation
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.
Results Reference
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Nutrigenomics Diet Intervention Study Comparing Effects of Western and Balanced Diet in Healthy Subjects

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