Effects of Fat and Carbohydrates in Obese Men

NCT01750021 | Completed

• 1 other identifier: 2011/2282
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Steatosis

Outcome Measures

Primary Outcomes (1)

• Changes in adipose tissue

  CT, body composition, molecular analyses of adipose tissue

  Baseline and 3 months and 6 months

Secondary Outcomes (6)

• Changes in metabolic parameters

  Baseline and 3 months and 6 months

• Changes in inflammatory parameters

  Baseline and 3 months and 6 months

• Changes in endocrine parameters

  Baseline and 3 months and 6 months

• Changes in metabolic health

  Baseline and 3 months and 6 months

• Changes in adipose tissue distribution

  Baseline and 3 months and 6 months

Study Arms (2)

High fat low carbohydrate diet

EXPERIMENTAL

High fat low carbohydrate diet

Dietary Supplement: High fat low carbohydrate diet

Low fat high carbohydrate diet

EXPERIMENTAL

Low fat high carbohydrate diet

Dietary Supplement: Low fat high carbohydrate diet

Interventions

High fat low carbohydrate diet DIETARY_SUPPLEMENT

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

High fat low carbohydrate diet

Low fat high carbohydrate diet DIETARY_SUPPLEMENT

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

Low fat high carbohydrate diet

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men.
• BMI 30-40.
• Fasting blood glucose \< 7 mM.
• Stable body weight last 2 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (1)

• 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.

  PMID: 27903520 RESULT

MeSH Terms

Conditions

Obesity; Fatty Liver

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Officials

• Gunnar Mellgren, MD PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 17, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 30, 2017

Record last verified: 2017-11

Locations

NO (1)