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Food and Health; Testing of the Anti-Inflammatory Potential of a Macronutrient Balanced Normocaloric Diet


N/A
16 Years
N/A
Not Enrolling
Female
Obesity, Diabetes Mellitus, Type 2, Cardiovascular Diseases

Thank you

Trial Information

Food and Health; Testing of the Anti-Inflammatory Potential of a Macronutrient Balanced Normocaloric Diet


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.


Inclusion Criteria:



- BMI > 35 kg/m2

Exclusion Criteria:

- Allergies (fish, nuts, eggs)

- Patient under treatment/using medicine that can influence results

- Pregnancy and lactation

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in microarray gene expression

Outcome Description:

Changes in microarray gene expression profiles in blood from morbid obese women, in response to balanced dietary macro nutrient composition

Outcome Time Frame:

Day 1, 4 and 14

Safety Issue:

No

Principal Investigator

Berit Johansen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Norwegian University of Science and Technology

Authority:

Norway: Regional Ethics Commitee

Study ID:

2010.1122.3

NCT ID:

NCT01278121

Start Date:

February 2011

Completion Date:

January 2012

Related Keywords:

  • Obesity
  • Diabetes Mellitus, Type 2
  • Cardiovascular Diseases
  • Obesity
  • Diabetes Mellitus, Type 2
  • Cardiovascular diseases
  • Cardiovascular Diseases
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Obesity

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