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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Diabetes Mellitus, Type 2, Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Diet A
* Dietary Supplement: Diet B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 35 kg/m2 Exclusion Criteria: Allergies (fish, nuts, eggs) Patient under treatment/using medicine that can influence results Pregnancy and lactation

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diet A: High-fat diet<br>Diet given for 3 days to reset all of the participants | Dietary Supplement: Diet A<br>* 3 days, 6 meals a day<br>* Other names: Obesity;|
| Active Comparator: Diet B: A carbohydrate-restricted diet<br>The diet will be given for 10 days, 6 meals a day | Dietary Supplement: Diet B<br>* 10 days, 6 meals a day<br>* Other names: Low carbohydrate diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 1, 4 and 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers, hormonal dietary responses and blood lipids | Blood will be screened for hormones, blood lipids and other inflammatory biomarkers | Day 1, 4 and 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Diabetes Mellitus, Type 2, Cardiovascular diseases