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Effects of Fat and Carbohydrates in Obese Men (FATFUNC)

Primary Purpose

Obesity, Steatosis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
High fat low carbohydrate diet
Low fat high carbohydrate diet
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

30 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High fat low carbohydrate diet

Low fat high carbohydrate diet

Arm Description

High fat low carbohydrate diet

Low fat high carbohydrate diet

Outcomes

Primary Outcome Measures

Changes in adipose tissue
CT, body composition, molecular analyses of adipose tissue

Secondary Outcome Measures

Changes in metabolic parameters
Molecular and biochemical analyses of tissue, blood and urine
Changes in inflammatory parameters
Molecular and biochemical analyses of tissue, blood and urine
Changes in endocrine parameters
Molecular and biochemical analyses of tissue, blood and urine
Changes in metabolic health
Clinical and biochemical data
Changes in adipose tissue distribution
Evaluation of adipose tissue distribution by CT
Changes in steatosis
Evaluation by CT

Full Information

First Posted
December 10, 2012
Last Updated
November 29, 2017
Sponsor
Haukeland University Hospital
Collaborators
University of Bergen
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1. Study Identification

Unique Protocol Identification Number
NCT01750021
Brief Title
Effects of Fat and Carbohydrates in Obese Men
Acronym
FATFUNC
Official Title
Comparison of Two Weight Reducing Diets in Obese Men
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
University of Bergen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Steatosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High fat low carbohydrate diet
Arm Type
Experimental
Arm Description
High fat low carbohydrate diet
Arm Title
Low fat high carbohydrate diet
Arm Type
Experimental
Arm Description
Low fat high carbohydrate diet
Intervention Type
Dietary Supplement
Intervention Name(s)
High fat low carbohydrate diet
Intervention Description
70E% fat, 20E% protein, 10E% carbohydrates
Intervention Type
Dietary Supplement
Intervention Name(s)
Low fat high carbohydrate diet
Intervention Description
20E% fat, 20E% protein, 60E% carbohydrates
Primary Outcome Measure Information:
Title
Changes in adipose tissue
Description
CT, body composition, molecular analyses of adipose tissue
Time Frame
Baseline and 3 months and 6 months
Secondary Outcome Measure Information:
Title
Changes in metabolic parameters
Description
Molecular and biochemical analyses of tissue, blood and urine
Time Frame
Baseline and 3 months and 6 months
Title
Changes in inflammatory parameters
Description
Molecular and biochemical analyses of tissue, blood and urine
Time Frame
Baseline and 3 months and 6 months
Title
Changes in endocrine parameters
Description
Molecular and biochemical analyses of tissue, blood and urine
Time Frame
Baseline and 3 months and 6 months
Title
Changes in metabolic health
Description
Clinical and biochemical data
Time Frame
Baseline and 3 months and 6 months
Title
Changes in adipose tissue distribution
Description
Evaluation of adipose tissue distribution by CT
Time Frame
Baseline and 3 months and 6 months
Title
Changes in steatosis
Description
Evaluation by CT
Time Frame
Baseline and 3 months and 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Mellgren, MD PhD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
27903520
Citation
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.
Results Reference
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Effects of Fat and Carbohydrates in Obese Men

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