An interventional study of Diet A and Diet B in Obesity, Diabetes Mellitus, Type 2 and Cardiovascular Diseases, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-18.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 28 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Diet given for 3 days to "reset" all of the participants
Dietary Supplement: Diet A
The diet will be given for 10 days, 6 meals a day
Dietary Supplement: Diet B
3 days, 6 meals a day
Also known as: Diet intervention, Obesity
10 days, 6 meals a day
Also known as: Low carbohydrate diet
Changes in microarray gene expression
Changes in microarray gene expression profiles in blood from morbid obese women, in response to balanced dietary macro nutrient composition
Time frame: Day 1, 4 and 14
Inflammatory markers, hormonal dietary responses and blood lipids
Blood will be screened for hormones, blood lipids and other inflammatory biomarkers
Time frame: Day 1, 4 and 14
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Norwegian University of Science and Technology