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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01750021
Other study ID # 2011/2282
Secondary ID
Status Completed
Phase N/A
First received December 10, 2012
Last updated November 29, 2017
Start date December 2012
Est. completion date December 2014

Study information

Verified date November 2017
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obesity has become a global epidemic, and treating and preventing obesity appears to be one of the world's greatest challenges. The disorder is associated with a wide range of metabolic and hormonal changes, including the development of insulin resistance, changes in adipose tissue function, increased levels of blood lipids, cardiovascular disease and obesity induced fatty liver. Obesity is characterized by inflammation in adipose tissue, altered fat storage capacity and increased exchange of lipids between adipose tissue and blood, and increased secretion of cytokines from adipose tissue. Cytokines are believed to play a central role in the regulation of adipose tissue, the size of adipocytes and other metabolic conditions.

The hepatic synthesis of lipoproteins and interaction with adipose tissue is essential for the body's energy storages. The central role of the liver in energy supply, fat storage and normalization of blood values implies the importance of investigating the interaction between adipose tissue and liver to increase knowledge about the morbidity of obesity. Central obesity and insulin resistance are clear risk factors for the development of fatty liver, but the importance of diet is unclear. The common perception is that fatty liver condition can be improved by a reduction in dietary fat and cholesterols, but the relationship is unclear, and contradictory findings occur in epidemiological studies. It is therefore necessary to better understand the impact of the different macro-nutrients.

The purpose of this study is to determine whether two weight reducing diets with equal calorie levels that contain high or low fat differentially affects the adipose tissue function, distribution of body fat, as well as tissue, blood and urine levels of inflammatory markers, lipids, vitamins, hormones and other substances that may be related to metabolically health.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria.

- Healthy men.

- BMI 30-40.

- Fasting blood glucose < 7 mM.

- Stable body weight last 2 months.

Exclusion Criteria.

- High intake of alcohol.

- Medication affecting glucose or lipid metabolism.

- Allergy towards important food items in the diet.

- Inflammatory bowel disease.

- Surgery or use of antibiotics last 2 months.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
High fat low carbohydrate diet
70E% fat, 20E% protein, 10E% carbohydrates
Low fat high carbohydrate diet
20E% fat, 20E% protein, 60E% carbohydrates

Locations

Country Name City State
Norway Haukeland University Hospital Bergen

Sponsors (2)

Lead Sponsor Collaborator
Haukeland University Hospital University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Veum VL, Laupsa-Borge J, Eng Ø, Rostrup E, Larsen TH, Nordrehaug JE, Nygård OK, Sagen JV, Gudbrandsen OA, Dankel SN, Mellgren G. Visceral adiposity and metabolic syndrome after very high-fat and low-fat isocaloric diets: a randomized controlled trial. Am — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in adipose tissue CT, body composition, molecular analyses of adipose tissue Baseline and 3 months and 6 months
Secondary Changes in metabolic parameters Molecular and biochemical analyses of tissue, blood and urine Baseline and 3 months and 6 months
Secondary Changes in inflammatory parameters Molecular and biochemical analyses of tissue, blood and urine Baseline and 3 months and 6 months
Secondary Changes in endocrine parameters Molecular and biochemical analyses of tissue, blood and urine Baseline and 3 months and 6 months
Secondary Changes in metabolic health Clinical and biochemical data Baseline and 3 months and 6 months
Secondary Changes in adipose tissue distribution Evaluation of adipose tissue distribution by CT Baseline and 3 months and 6 months
Secondary Changes in steatosis Evaluation by CT Baseline and 3 months and 6 months
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