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Study of the Potential of a Macronutrient Balanced Normocaloric Diet to Treat Lifestyle Diseases

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01278121
First received: July 4, 2010
Last updated: February 3, 2012
Last verified: February 2012

July 4, 2010
February 3, 2012
February 2011
December 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01278121 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Study of the Potential of a Macronutrient Balanced Normocaloric Diet to Treat Lifestyle Diseases
Food and Health; Testing of the Anti-Inflammatory Potential of a Macronutrient Balanced Normocaloric Diet

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Diabetes Mellitus, Type 2
  • Cardiovascular Diseases
  • Dietary Supplement: Diet A
    3 days, 6 meals a day
    Other Names:
    • Diet intervention
    • Obesity
  • Dietary Supplement: Diet B
    10 days, 6 meals a day
    Other Name: Low carbohydrate diet
  • Diet A: High-fat diet
    Diet given for 3 days to "reset" all of the participants
    Intervention: Dietary Supplement: Diet A
  • Active Comparator: Diet B: A carbohydrate-restricted diet
    The diet will be given for 10 days, 6 meals a day
    Intervention: Dietary Supplement: Diet B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
January 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI > 35 kg/m2

Exclusion Criteria:

  • Allergies (fish, nuts, eggs)
  • Patient under treatment/using medicine that can influence results
  • Pregnancy and lactation
Female
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01278121
2010.1122.3
Yes
Norwegian University of Science and Technology
Norwegian University of Science and Technology
St. Olavs Hospital
Principal Investigator: Berit Johansen, PhD Norwegian University of Science and Technology
Study Chair: Marian Forde, Cand.Scient. Norwegian University of Science and Technology
Norwegian University of Science and Technology
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP