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

Not Applicable

Completed

• Conditions: Obesity; Cardiovascular Diseases; Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Diet A; Dietary Supplement: Diet B

• Registration Number: NCT01278121
• Lead Sponsor: Norwegian University of Science and Technology

Brief 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.

Study Timeline

• Study First Submitted: 2010-07-04
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-17
• Study Start: 2011-02
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

• BMI > 35 kg/m2

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Diet A: High-fat diet	Diet A	Diet given for 3 days to "reset" all of the participants
Diet B: A carbohydrate-restricted diet	Diet B	The diet will be given for 10 days, 6 meals a day

Primary Outcome Measures

Name	Time	Method
Changes in microarray gene expression	Day 1, 4 and 14	Changes in microarray gene expression profiles in blood from morbid obese women, in response to balanced dietary macro nutrient composition

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers, hormonal dietary responses and blood lipids	Day 1, 4 and 14	Blood will be screened for hormones, blood lipids and other inflammatory biomarkers

Trial Locations

Locations (1)

NTNU Department of Biology; 🇳🇴 Trondheim, Norway