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

Norwegian University of Science and Technology

Status: Completed

Conditions: Obesity; Cardiovascular Diseases; Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: Diet B; Dietary Supplement: Diet A

Study type: Interventional

Funder types: Other

Identifiers

NCT01278121

2010.1122.3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI > 35 kg/m2

Exclusion criteria

• Allergies (fish, nuts, eggs)
• Patient under treatment/using medicine that can influence results
• Pregnancy and lactation

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Diet A: High-fat diet

Other group

Description:

Diet given for 3 days to "reset" all of the participants

Treatment:

Dietary Supplement: Diet A

Diet B: A carbohydrate-restricted diet

Active Comparator group

Description:

The diet will be given for 10 days, 6 meals a day

Treatment:

Dietary Supplement: Diet B