Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2012-12-31
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
High fat low carbohydrate diet
High fat low carbohydrate diet
High fat low carbohydrate diet
70E% fat, 20E% protein, 10E% carbohydrates
Low fat high carbohydrate diet
Low fat high carbohydrate diet
Low fat high carbohydrate diet
20E% fat, 20E% protein, 60E% carbohydrates
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
High fat low carbohydrate diet
70E% fat, 20E% protein, 10E% carbohydrates
Low fat high carbohydrate diet
20E% fat, 20E% protein, 60E% carbohydrates
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI 30-40.
* Fasting blood glucose \< 7 mM.
* Stable body weight last 2 months.
Exclusion Criteria
* 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.
30 Years
50 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Bergen
OTHER
Haukeland University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gunnar Mellgren, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Haukeland University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Haukeland University Hospital
Bergen, , Norway
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011/2282
Identifier Type: -
Identifier Source: org_study_id