Nutrigenomics Diet Intervention Study Comparing Effects of Western and Balanced Diet in Healthy Subjects
Foodgene
Health Risk Assessment of Dietary Carbohydrates in Chronic Disease Development
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cardiovascular-diseases
Started Dec 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 11, 2008
CompletedFirst Posted
Study publicly available on registry
August 12, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJanuary 30, 2017
January 1, 2017
6 months
August 11, 2008
January 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Inflammatory markers, hormonal dietary responses and blood lipids
Before and after each of two 6-days diet intervention periods
Study Arms (2)
A
ACTIVE COMPARATORDiet A - Western diet
B
ACTIVE COMPARATORDiet B - Balanced diet
Interventions
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.
Eligibility Criteria
You may qualify if:
- healthy
- BMI 24.5-27.5
- pass health check criteria
You may not qualify if:
- chronic diseases
- inflammation
- pregnancy and lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
- FUGE Mid-Norwaycollaborator
Study Sites (1)
Norwegian University of Science and Technology
Trondheim, 7491, Norway
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: 21679058BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Berit Johansen, PhD
Norwegian University of Sciense and Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2008
First Posted
August 12, 2008
Study Start
December 1, 2007
Primary Completion
June 1, 2008
Study Completion
July 1, 2009
Last Updated
January 30, 2017
Record last verified: 2017-01