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

January 27, 2017 updated by: Norwegian University of Science and Technology

Health Risk Assessment of Dietary Carbohydrates in Chronic Disease Development

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7491
        • Norwegian University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • chronic diseases
  • inflammation
  • pregnancy and lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Diet A - Western diet
Behavioral: "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.
Other Names:
  • western diet
  • high-carbohydrate, low fat, low protein diet
  • balanced diet
  • low-carbohydrate, high fat, high protein diet
Active Comparator: B
Diet B - Balanced diet
Behavioral: "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.
Other Names:
  • western diet
  • high-carbohydrate, low fat, low protein diet
  • balanced diet
  • low-carbohydrate, high fat, high protein diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Before and after each of two 6-days diet intervention periods

Secondary Outcome Measures

Outcome Measure
Time Frame
Inflammatory markers, hormonal dietary responses and blood lipids
Time Frame: Before and after each of two 6-days diet intervention periods
Before and after each of two 6-days diet intervention periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital
FUGE Mid-Norway

Investigators

  • Principal Investigator: Berit Johansen, PhD, Norwegian University of Sciense and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

August 11, 2008

First Submitted That Met QC Criteria

August 11, 2008

First Posted (Estimate)

August 12, 2008

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK 4.2007.515
  • 16649 (Other Identifier: NSD)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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