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Effects of Fat and Carbohydrates in Obese Men

Comparison of Two Weight Reducing Diets in Obese Men

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01750021
Acronym
FATFUNC
Enrollment
40
Registered
2012-12-17
Start date
2012-12-31
Completion date
2014-12-31
Last updated
2017-11-30

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

Conditions

Obesity, Steatosis

Brief 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.

Interventions

70E% fat, 20E% protein, 10E% carbohydrates

20E% fat, 20E% protein, 60E% carbohydrates

Sponsors

University of Bergen
CollaboratorOTHER
Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
30 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in adipose tissueBaseline and 3 months and 6 monthsCT, body composition, molecular analyses of adipose tissue

Secondary

MeasureTime frameDescription
Changes in inflammatory parametersBaseline and 3 months and 6 monthsMolecular and biochemical analyses of tissue, blood and urine
Changes in endocrine parametersBaseline and 3 months and 6 monthsMolecular and biochemical analyses of tissue, blood and urine
Changes in metabolic parametersBaseline and 3 months and 6 monthsMolecular and biochemical analyses of tissue, blood and urine
Changes in adipose tissue distributionBaseline and 3 months and 6 monthsEvaluation of adipose tissue distribution by CT
Changes in steatosisBaseline and 3 months and 6 monthsEvaluation by CT
Changes in metabolic healthBaseline and 3 months and 6 monthsClinical and biochemical data

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026