Effects of Fat and Carbohydrates in Obese Men

Obesity Clinical Trial

— FATFUNC  

Official title:

Comparison of Two Weight Reducing Diets in Obese Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750021
• Other study ID #: 2011/2282
• Status: Completed
• Phase: N/A
• First received: December 10, 2012
• Last updated: November 29, 2017
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: November 2017
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Steatosis

Intervention

Dietary Supplement:
• High fat low carbohydrate diet
70E% fat, 20E% protein, 10E% carbohydrates
• Low fat high carbohydrate diet
20E% fat, 20E% protein, 60E% carbohydrates

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Veum VL, Laupsa-Borge J, Eng Ø, Rostrup E, Larsen TH, Nordrehaug JE, Nygård 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in adipose tissue	CT, body composition, molecular analyses of adipose tissue	Baseline and 3 months and 6 months
Secondary	Changes in metabolic parameters	Molecular and biochemical analyses of tissue, blood and urine	Baseline and 3 months and 6 months
Secondary	Changes in inflammatory parameters	Molecular and biochemical analyses of tissue, blood and urine	Baseline and 3 months and 6 months
Secondary	Changes in endocrine parameters	Molecular and biochemical analyses of tissue, blood and urine	Baseline and 3 months and 6 months
Secondary	Changes in metabolic health	Clinical and biochemical data	Baseline and 3 months and 6 months
Secondary	Changes in adipose tissue distribution	Evaluation of adipose tissue distribution by CT	Baseline and 3 months and 6 months
Secondary	Changes in steatosis	Evaluation by CT	Baseline and 3 months and 6 months