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Effects of Fat and Carbohydrates in Obese Men (FATFUNC)

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ClinicalTrials.gov Identifier: NCT01750021
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : November 30, 2017
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Haukeland University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Obesity Steatosis Dietary Supplement: High fat low carbohydrate diet Dietary Supplement: Low fat high carbohydrate diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparison of Two Weight Reducing Diets in Obese Men
Study Start Date : December 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: High fat low carbohydrate diet
High fat low carbohydrate diet
 Dietary Supplement: High fat low carbohydrate diet
70E% fat, 20E% protein, 10E% carbohydrates
Experimental: Low fat high carbohydrate diet
Low fat high carbohydrate diet
 Dietary Supplement: Low fat high carbohydrate diet
20E% fat, 20E% protein, 60E% carbohydrates


Outcome Measures
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Primary Outcome Measures :
  1. Changes in adipose tissue [ Time Frame: Baseline and 3 months and 6 months ]
    CT, body composition, molecular analyses of adipose tissue


Secondary Outcome Measures :
  1. Changes in metabolic parameters [ Time Frame: Baseline and 3 months and 6 months ]
    Molecular and biochemical analyses of tissue, blood and urine

  2. Changes in inflammatory parameters [ Time Frame: Baseline and 3 months and 6 months ]
    Molecular and biochemical analyses of tissue, blood and urine

  3. Changes in endocrine parameters [ Time Frame: Baseline and 3 months and 6 months ]
    Molecular and biochemical analyses of tissue, blood and urine

  4. Changes in metabolic health [ Time Frame: Baseline and 3 months and 6 months ]
    Clinical and biochemical data

  5. Changes in adipose tissue distribution [ Time Frame: Baseline and 3 months and 6 months ]
    Evaluation of adipose tissue distribution by CT

  6. Changes in steatosis [ Time Frame: Baseline and 3 months and 6 months ]
    Evaluation by CT


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750021


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

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01750021     History of Changes
Other Study ID Numbers: 2011/2282
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017