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NCT Number: NCT01278121

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

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NTNU Department of Biology

Trondheim, 7491, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI > 35 kg/m2

Exclusion criteria

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

Treatment and study plan

Diet A

Dietary Supplement

3 days, 6 meals a day

Other names: Diet intervention, Obesity

Diet B

Dietary Supplement

10 days, 6 meals a day

Other names: Low carbohydrate diet

Primary outcomes

  1. Changes in microarray gene expression

    Time frame: 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 outcomes

  1. Inflammatory markers, hormonal dietary responses and blood lipids

    Time frame: Day 1, 4 and 14

    Blood will be screened for hormones, blood lipids and other inflammatory biomarkers

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jan 17, 2011
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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