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

NCT ID: NCT01278121

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-01-31

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.

Conditions

Obesity; Diabetes Mellitus, Type 2; Cardiovascular Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diet A: High-fat diet

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

Group Type: OTHER

Diet A

Intervention Type: DIETARY_SUPPLEMENT

3 days, 6 meals a day

Diet B: A carbohydrate-restricted diet

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

Group Type: ACTIVE_COMPARATOR

Diet B

Intervention Type: DIETARY_SUPPLEMENT

10 days, 6 meals a day

Interventions

Diet A

3 days, 6 meals a day

Intervention Type: DIETARY_SUPPLEMENT

Diet B

10 days, 6 meals a day

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Diet intervention; Obesity; Low carbohydrate diet

Eligibility Criteria

Inclusion Criteria

• BMI > 35 kg/m2

Exclusion Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Berit Johansen, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Marian Forde, Cand.Scient.

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Locations

NTNU Department of Biology

Trondheim, Trondheim, Norway

Countries

Norway

References

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(1):41-52. doi: 10.1089/omi.2010.0124. Epub 2011 Jun 16.

Reference Type: RESULT

PMID: 21679058 (View on PubMed)

Other Identifiers

2010.1122.3

Identifier Type: -

Identifier Source: org_study_id