Study of the Potential of a Macronutrient Balanced Normocaloric Diet to Treat Lifestyle Diseases
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| First Received Date ICMJE | July 4, 2010 | ||||||||
| Last Updated Date | February 3, 2012 | ||||||||
| Start Date ICMJE | February 2011 | ||||||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Changes in microarray gene expression [ Time Frame: Day 1, 4 and 14 ] [ Designated as safety issue: No ] Changes in microarray gene expression profiles in blood from morbid obese women, in response to balanced dietary macro nutrient composition |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01278121 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Inflammatory markers, hormonal dietary responses and blood lipids [ Time Frame: Day 1, 4 and 14 ] [ Designated as safety issue: No ] Blood will be screened for hormones, blood lipids and other inflammatory biomarkers |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of the Potential of a Macronutrient Balanced Normocaloric Diet to Treat Lifestyle Diseases | ||||||||
| Official Title ICMJE | Food and Health; Testing of the Anti-Inflammatory Potential of a Macronutrient Balanced Normocaloric Diet | ||||||||
| Brief Summary | One of today's major health problem in the western world is related to lifestyle. Lifestyle diseases include obesity, T2D (type 2 diabetes), cardiovascular diseases and different types of cancers. For many years, a low-fat diet has been recommended to reduce obesity and lifestyle diseases, but by replacing fat with carbohydrates has lead to an increase of these diseases. Overweight is associated with a cronical low-degree inflammation, and later studies has shown that carbohydrates has an effect on the mecanisms of inflammation. Previous studies in the investigators group has shown that in healthy, but slightly overweight persons, a balanced diet of lower carbohydrate content regulates the gene expression in a manner that leads to less inflammation. In this study the investigators will look at morbid obese women (BMI>35) to see if the same, balanced diet can improve the inflammatory profile of the women. |
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| Detailed Description | The hypothesis of this proposal is that a carbohydrate-rich diet may cause a major deregulation of hormonal balance, causing both acute and chronic systemic inflammatory reactions mediated by white blood cells. We furthermore postulate that a carbohydrate-rich diet is an underexplored major risk factor in the development of obesity and life style diseases directly resulting from chronic systemic inflammation. We therefore want to use an integrated multidisciplinary systems biology approach to identify the hormones, genes and pathways specifically responding to a dietary carbohydrate reduction, to develop biomarkers that can be used for risk assessment, to identify molecular pathways and build mathematical models that describe the link between diet and inflammation, and use this knowledge to provide personalised dietary advice. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 28 | ||||||||
| Completion Date | January 2012 | ||||||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 16 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01278121 | ||||||||
| Other Study ID Numbers ICMJE | 2010.1122.3 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Norwegian University of Science and Technology | ||||||||
| Study Sponsor ICMJE | Norwegian University of Science and Technology | ||||||||
| Collaborators ICMJE | St. Olavs Hospital | ||||||||
| Investigators ICMJE |
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| Information Provided By | Norwegian University of Science and Technology | ||||||||
| Verification Date | February 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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