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

This study has been completed.
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology Identifier:
First received: July 4, 2010
Last updated: January 16, 2017
Last verified: January 2017
One of today's major health problem in the western world is related to lifestyle. Lifestyle diseases include obesity, 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 replacing fat with carbohydrates has lead to an increase of these diseases. Overweight is associated with a chronical low-degree inflammation, and later studies have shown that carbohydrates have an effect on the mechanisms 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.

Condition Intervention
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Dietary Supplement: Diet A
Dietary Supplement: Diet B

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Food and Health; Testing of the Anti-Inflammatory Potential of a Macronutrient Balanced Normocaloric Diet

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Changes in microarray gene expression [ Time Frame: Day 1, 4 and 14 ]
    Changes in microarray gene expression profiles in blood from morbid obese women, in response to balanced dietary macro nutrient composition

Secondary Outcome Measures:
  • Inflammatory markers, hormonal dietary responses and blood lipids [ Time Frame: Day 1, 4 and 14 ]
    Blood will be screened for hormones, blood lipids and other inflammatory biomarkers

Enrollment: 28
Study Start Date: February 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Diet A: High-fat diet
Diet given for 3 days to "reset" all of the participants
Dietary Supplement: Diet A
3 days, 6 meals a day
Other Names:
  • Diet intervention
  • Obesity
Active Comparator: Diet B: A carbohydrate-restricted diet
The diet will be given for 10 days, 6 meals a day
Dietary Supplement: Diet B
10 days, 6 meals a day
Other Name: Low carbohydrate diet

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 a 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.

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • BMI > 35 kg/m2

Exclusion Criteria:

  • Allergies (fish, nuts, eggs)
  • Patient under treatment/using medicine that can influence results
  • Pregnancy and lactation
  Contacts and Locations
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Please refer to this study by its identifier: NCT01278121

NTNU Department of Biology
Trondheim, Norway, 7491
Sponsors and Collaborators
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
  More Information

Responsible Party: Norwegian University of Science and Technology Identifier: NCT01278121     History of Changes
Other Study ID Numbers: 2010.1122.3
Study First Received: July 4, 2010
Last Updated: January 16, 2017

Keywords provided by Norwegian University of Science and Technology:
Diabetes Mellitus, Type 2
Cardiovascular diseases

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on May 25, 2017