Effects of Fat and Carbohydrates in Obese Men (FATFUNC)

Comparison of Two Weight Reducing Diets in Obese Men

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Steatosis
• Intervention / Treatment: Dietary supplement: High fat low carbohydrate diet; Dietary supplement: Low fat high carbohydrate diet

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High fat low carbohydrate diet	Dietary supplement: High fat low carbohydrate diet; 70E% fat, 20E% protein, 10E% carbohydrates
Experimental: Low fat high carbohydrate diet	Dietary supplement: Low fat high carbohydrate diet; 20E% fat, 20E% protein, 60E% carbohydrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in adipose tissue	CT, body composition, molecular analyses of adipose tissue	Baseline and 3 months and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University of Bergen
• Investigators: Principal Investigator: Gunnar Mellgren, MD PhD, Haukeland University Hospital

Publications and helpful links

General Publications

• Veum VL, Laupsa-Borge J, Eng O, Rostrup E, Larsen TH, Nordrehaug JE, Nygard 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 J Clin Nutr. 2017 Jan;105(1):85-99. doi: 10.3945/ajcn.115.123463. Epub 2016 Nov 30.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 12, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: 2011/2282