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

Health Risk Assessment of Dietary Carbohydrates in Chronic Disease Development

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00733018
Acronym
Foodgene
Enrollment
40
Registered
2008-08-12
Start date
2007-12-31
Completion date
2009-07-31
Last updated
2017-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Chronic Disease

Keywords

Nutrigenomics, Gene Expression, Diet, Carbohydrate-Restricted, Life Style, Health Behavior

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.

Interventions

BEHAVIORALWestern 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.

Sponsors

St. Olavs Hospital
CollaboratorOTHER
FUGE Mid-Norway
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* chronic diseases * inflammation * pregnancy and lactation

Design outcomes

Primary

MeasureTime 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.Before and after each of two 6-days diet intervention periods

Secondary

MeasureTime frame
Inflammatory markers, hormonal dietary responses and blood lipidsBefore and after each of two 6-days diet intervention periods

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026