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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
History of Changes
  Purpose

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.


Condition Intervention
Obesity
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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ 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


Secondary Outcome Measures:
  • 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


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 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278121

Locations
Norway
NTNU Department of Biology
Trondheim, Norway, 7491
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01278121     History of Changes
Other Study ID Numbers: 2010.1122.3
Study First Received: July 4, 2010
Last Updated: February 3, 2012
Health Authority: Norway: Regional Ethics Commitee

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013