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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01278121
Enrollment
28
Registered
2011-01-17
Start date
2011-02-28
Completion date
2012-01-31
Last updated
2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Diabetes Mellitus, Type 2, Obesity

Keywords

Obesity, Diabetes Mellitus, Type 2, Cardiovascular diseases

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.

Interventions

DIETARY_SUPPLEMENTDiet A

3 days, 6 meals a day

DIETARY_SUPPLEMENTDiet B

10 days, 6 meals a day

Sponsors

St. Olavs Hospital
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* BMI \> 35 kg/m2

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in microarray gene expressionDay 1, 4 and 14Changes in microarray gene expression profiles in blood from morbid obese women, in response to balanced dietary macro nutrient composition

Secondary

MeasureTime frameDescription
Inflammatory markers, hormonal dietary responses and blood lipidsDay 1, 4 and 14Blood will be screened for hormones, blood lipids and other inflammatory biomarkers

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026