Obesity Clinical Trial
— FATFUNCOfficial title:
Comparison of Two Weight Reducing Diets in Obese Men
Verified date | November 2017 |
Source | Haukeland University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital | Bergen |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital | University of Bergen |
Norway,
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
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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