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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278121
• Other study ID #: 2010.1122.3
• Status: Completed
• Phase: N/A
• First received: July 4, 2010
• Last updated: January 16, 2017
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• BMI > 35 kg/m2

Exclusion Criteria:

• Allergies (fish, nuts, eggs)

• Patient under treatment/using medicine that can influence results

• Pregnancy and lactation

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Dietary Supplement:
• Diet A
3 days, 6 meals a day
• Diet B
10 days, 6 meals a day

Locations

Country	Name	City	State
Norway	NTNU Department of Biology	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Brattbakk HR, Arbo I, Aagaard S, Lindseth I, de Soysa AK, Langaas M, Kulseng B, Lindberg F, Johansen B. Balanced caloric macronutrient composition downregulates immunological gene expression in human blood cells-adipose tissue diverges. OMICS. 2013 Jan;17 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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