Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230113
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2005-09-29
Brief Title:
Effect of Omega-3 PUFA Supplementation in NAFLD Patients
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
A Randomized Masked Controlled Study of Omega-3 Polyunsaturated Fatty Acid vs Monounsaturated Fatty Acid Diet Supplementation for the Treatment of Nonalcoholic Fatty Liver Disease
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether dietary supplementation with omega-3 polyunsaturated fatty acids will decrease the amount of fat in liver
Detailed Description:
NAFLD is the most common liver disease in the United States and is also a common cause of abnormal liver tests in the United States NAFLD includes mild as well as a more severe nonalcoholic fatty liver disease involving liver cell inflammation and damage called Nonalcoholic Steatohepatitis NASH NAFLD is usually discovered because of abnormal liver tests or from a liver ultrasound or CT scan in persons with normal liver enzymes Liver biopsy may show a mix of fat inflammation and scarring in the liver Patients with NAFLD do not drink large amounts of alcohol that can cause this type of liver damage NAFLD is thought to be related to obesity and diabetes Unfortunately there is very little information about important features of NAFLD These include biochemical genetic and other features that may help to predict disease progression The few known risk factors include high blood sugar and lipid levels Patients with NAFLD often have resistance to the normal action of insulin a hormone which is important for processing sugar and fat Increased resistance to insulin leads to fat in the liver Currently there is no proven treatment for NAFLD Several studies in animals suggest that diets containing high levels of omega-3 polyunsaturated fatty acids PUFA will decrease the amount of liver fat
It has long been known that omega-3 fatty acids have several health benefits For example a diet rich in these fatty acids reduces the amount of certain fats triglycerides in blood and might improve the action of the important hormone insulin Omega-3 fatty acids are contained in certain plant oils such as canola oil and linseed oil and marine fish such as salmon The purpose of this study is to determine the effect of dietary supplementation with ω-3 polyunsaturated vs monounsaturated fatty acids on intrahepatic fat content in patients with non-alcoholic fatty liver disease as determined by magnetic resonance spectroscopy
It has long been known that omega-3 fatty acids have several health benefits For example a diet rich in these fatty acids reduces the amount of certain fats triglycerides in blood and might improve the action of the important hormone insulin Omega-3 fatty acids are contained in certain plant oils such as canola oil and linseed oil and marine fish such as salmon The purpose of this study is to determine the effect of dietary supplementation with ω-3 polyunsaturated vs monounsaturated fatty acids on intrahepatic fat content in patients with non-alcoholic fatty liver disease as determined by magnetic resonance spectroscopy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None