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

NCT01278121 | Completed DMC

• 1 other identifier: 2010.1122.3
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes Mellitus, Type 2; Cardiovascular Diseases

Keywords

Obesity; Diabetes Mellitus, Type 2; Cardiovascular diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inflammatory markers, hormonal dietary responses and blood lipids

  Day 1, 4 and 14

Study Arms (2)

Diet A: High-fat diet

OTHER

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

Dietary Supplement: Diet A

Diet B: A carbohydrate-restricted diet

ACTIVE COMPARATOR

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

Dietary Supplement: Diet B

Interventions

Diet A DIETARY_SUPPLEMENT

3 days, 6 meals a day

Also known as: Diet intervention, Obesity

Diet A: High-fat diet

Diet B DIETARY_SUPPLEMENT

10 days, 6 meals a day

Also known as: Low carbohydrate diet

Diet B: A carbohydrate-restricted diet

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \> 35 kg/m2

You may not qualify if:

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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

NTNU Department of Biology

Trondheim, Trondheim, 7491, Norway

Location

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

  PMID: 21679058 RESULT

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Cardiovascular Diseases

Interventions

Adiposity; Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition

Study Officials

• Berit Johansen, PhD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Marian Forde, Cand.Scient.

  Norwegian University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2010
• First Posted: January 17, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

NO (1)