Cardiovascular DiseasesFoodgeneNCT00733018
Nutrigenomics Diet Intervention Study Comparing Effects of Western and Balanced Diet in Healthy Subjects
A study testing "Western" versus "balanced" macro nutrient diet composition in people with Cardiovascular Diseases and Chronic Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Chronic Disease
- What is being tested?
- "Western" versus "balanced" macro nutrient diet composition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2007to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- BMI 24.5-27.5
- pass health check criteria
Who cannot join
- chronic diseases
- inflammation
- pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- "Western" versus "balanced" macro nutrient diet composition
- Keywords
- Nutrigenomics, Gene Expression, Diet, Carbohydrate-Restricted, Life Style, Health Behavior
- Medical subject headings
- Cardiovascular Diseases, Chronic Disease, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Western" versus "balanced" macro nutrient diet compositionBehavioural
Also called western diet, high-carbohydrate, low fat, low protein diet, balanced diet, low-carbohydrate, high fat, high protein diet
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Diet A - Western diet Receives: Behavioral: "Western" versus "balanced" macro nutrient diet composition |
| B | Active comparator | Diet B - Balanced diet Receives: Behavioral: "Western" versus "balanced" macro nutrient diet composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in microarray gene expression profiles in blood from healthy young women and men, in response to western or balanced dietary macro nutrient composition.
Measured: Before and after each of two 6-days diet intervention periods
Secondary outcomes (1)
Inflammatory markers, hormonal dietary responses and blood lipids
Measured: Before and after each of two 6-days diet intervention periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, FUGE Mid-Norway
- Responsible party
- Sponsor
- Investigators
- Berit Johansen, PhD, Principal investigator, Norwegian University of Sciense and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733018
- Sponsor's protocol ID
- REK 4.2007.515
- Other IDs
- 16649
- Acronym
- Foodgene
- Status last verified
- Jan 2017
- First submitted
- 11 Aug 2008
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21679058
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Risk Assessment of Dietary Carbohydrates in Chronic Disease Development
- ClinicalTrials.gov ID
- NCT00733018
- Acronym / sponsor ID
- Foodgene / REK 4.2007.515
- Conditions
- Cardiovascular Diseases, Chronic Disease
- Keywords
- Nutrigenomics, Gene Expression, Diet, Carbohydrate-Restricted, Life Style, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, FUGE Mid-Norway
- Study start
- Dec 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 12 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Behavioral: "Western" versus "balanced" macro nutrient diet compositionDiet A - Western diet |
| B | Active comparator | Behavioral: "Western" versus "balanced" macro nutrient diet compositionDiet B - Balanced diet |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- BMI 24.5-27.5
- pass health check criteria
Key exclusion criteria (3 listed)
- chronic diseases
- inflammation
- pregnancy and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Western" versus "balanced" macro nutrient diet compositionAlso: western diet, high-carbohydrate, low fat, low protein diet, balanced diet, low-carbohydrate, high fat, high protein dietRandomized 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. | Behavioural | A, B |
Primary outcome
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
1 secondary outcome
Inflammatory markers, hormonal dietary responses and blood lipids
Time frame: Before and after each of two 6-days diet intervention periods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Background: PubMed 21679058Brattbakk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berit Johansen, PhD principal investigator
Norwegian University of Sciense and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Western" versus "balanced" macro nutrient diet composition in people with Cardiovascular Diseases and Chronic Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00733018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.