Skip to main content
OpenTrials
Completed

NCT Number: NCT01750021

Effects of Fat and Carbohydrates 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High fat low carbohydrate diet

Dietary Supplement

70E% fat, 20E% protein, 10E% carbohydrates

Low fat high carbohydrate diet

Dietary Supplement

20E% fat, 20E% protein, 60E% carbohydrates

Primary outcomes

  1. Changes in adipose tissue

    Time frame: Baseline and 3 months and 6 months

    CT, body composition, molecular analyses of adipose tissue

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • University of Bergen

Registry information

Official study title

Comparison of Two Weight Reducing Diets in Obese Men

Acronym: FATFUNC

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 17, 2012
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.