Clinical Trials Directory

Trials / Completed

CompletedNCT01278121

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
28 (actual)
Sponsor
Norwegian University of Science and Technology · Academic / Other
Sex
Female
Age
16 Years
Healthy volunteers
Accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTDiet A3 days, 6 meals a day
DIETARY_SUPPLEMENTDiet B10 days, 6 meals a day

Timeline

Start date
2011-02-01
Primary completion
2011-12-01
Completion
2012-01-01
First posted
2011-01-17
Last updated
2017-01-18

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT01278121. Inclusion in this directory is not an endorsement.