Effects of Fat and Carbohydrates in Obese Men

Not Applicable

Completed

• Conditions: Obesity; Steatosis
• Interventions: Dietary Supplement: High fat low carbohydrate diet; Dietary Supplement: Low fat high carbohydrate diet

• Registration Number: NCT01750021
• Lead Sponsor: Haukeland University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-17
• Primary Completion: 2014-01
• Study Completion: 2014-12
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-29
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High fat low carbohydrate diet	High fat low carbohydrate diet	High fat low carbohydrate diet
Low fat high carbohydrate diet	Low fat high carbohydrate diet	Low fat high carbohydrate diet

Primary Outcome Measures

Name	Time	Method
Changes in adipose tissue	Baseline and 3 months and 6 months	CT, body composition, molecular analyses of adipose tissue

Secondary Outcome Measures

Name	Time	Method
Changes in metabolic parameters	Baseline and 3 months and 6 months	Molecular and biochemical analyses of tissue, blood and urine
Changes in steatosis	Baseline and 3 months and 6 months	Evaluation by CT
Changes in endocrine parameters	Baseline and 3 months and 6 months	Molecular and biochemical analyses of tissue, blood and urine
Changes in metabolic health	Baseline and 3 months and 6 months	Clinical and biochemical data
Changes in adipose tissue distribution	Baseline and 3 months and 6 months	Evaluation of adipose tissue distribution by CT
Changes in inflammatory parameters	Baseline and 3 months and 6 months	Molecular and biochemical analyses of tissue, blood and urine

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway