Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Fat and Carbohydrates in Obese Men (FATFUNC)

This study is enrolling participants by invitation only.
University of Bergen
Information provided by (Responsible Party):
Haukeland University Hospital Identifier:
First received: December 10, 2012
Last updated: January 5, 2014
Last verified: January 2014

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.

Condition Intervention
Dietary Supplement: High fat low carbohydrate diet
Dietary Supplement: Low fat high carbohydrate diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Comparison of Two Weight Reducing Diets in Obese Men

Resource links provided by NLM:

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Changes in adipose tissue [ Time Frame: Baseline and 3 months and 6 months ] [ Designated as safety issue: No ]
    CT, body composition, molecular analyses of adipose tissue

Secondary Outcome Measures:
  • Changes in metabolic parameters [ Time Frame: Baseline and 3 months and 6 months ] [ Designated as safety issue: No ]
    Molecular and biochemical analyses of tissue, blood and urine

  • Changes in inflammatory parameters [ Time Frame: Baseline and 3 months and 6 months ] [ Designated as safety issue: No ]
    Molecular and biochemical analyses of tissue, blood and urine

  • Changes in endocrine parameters [ Time Frame: Baseline and 3 months and 6 months ] [ Designated as safety issue: No ]
    Molecular and biochemical analyses of tissue, blood and urine

  • Changes in metabolic health [ Time Frame: Baseline and 3 months and 6 months ] [ Designated as safety issue: No ]
    Clinical and biochemical data

  • Changes in adipose tissue distribution [ Time Frame: Baseline and 3 months and 6 months ] [ Designated as safety issue: No ]
    Evaluation of adipose tissue distribution by CT

  • Changes in steatosis [ Time Frame: Baseline and 3 months and 6 months ] [ Designated as safety issue: No ]
    Evaluation by CT

Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Male
Accepts 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01750021

Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Principal Investigator: Gunnar Mellgren, MD PhD Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Haukeland University Hospital Identifier: NCT01750021     History of Changes
Other Study ID Numbers: 2011/2282
Study First Received: December 10, 2012
Last Updated: January 5, 2014
Health Authority: Norway: Regional Ethics Commitee processed this record on February 25, 2015