NCT03132662

Omega-3 vs Very Low Calorie Diet for Liver Size Reduction

Comparative Trial of Omega-3 Polyunsaturated Fatty Acids vs a Very Low Calorie Liquid Diet for Liver Volume Reduction Prior to Bariatric Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A recent review demonstrated that Non-alcoholic fatty liver disease (NAFLD) affects 10-35% of the adult population worldwide, with the prevalence approaching 85-100% in obese populations. Current standard treatment for liver reduction before surgery is the use of a very low calorie liquid diet (VLCLD). Multiple studies have shown that a 2-4 week diet with a VLCD will reduce liver volume, in preparation for surgery. Omega-3 (Ω-3) polyunsaturated fatty acids (PUFAs) have been suggested as a treatment for NAFLD. The primary aim of this study is to compare Ω-3 PUFAs and a VLCLD and their effect on left lobe live size before bariatric surgery.

Detailed description

Non-alcoholic fatty liver disease (NAFLD) is defined by the pathological accumulation of fat in the liver when no other explanatory disease is present: it encompasses isolated hepatic steatosis, non-alcoholic steatohepatitis (NASH) cirrhosis, and is a frequent accompaniment of obesity and insulin resistance. A recent review demonstrated that NAFLD affects 10-35% of the adult population worldwide, with the prevalence approaching 85-100% in obese populations. Although frequently asymptomatic and relatively benign, NAFLD has the potential to progress to cirrhosis. Cirrhosis, when decompensated, has a poor prognosis. Also, NAFDL will be accompanied invariably with increased liver volume, which will directly increase the level of difficulty of upper gastrointestinal surgery, such as bariatric surgery, specifically for the visualization of the gastro-esophageal junction. Bleeding is also more frequent with larger fattier left liver lobes. The combination of these factors may lead to conversion to open surgery, thus: increasing postoperative pain due to larger incisions, prolonging postoperative recovery times and increasing the risks of infection and hernias. Current standard treatment for liver reduction before surgery is the use of a very low calorie liquid diet (VLCLD). Multiple studies have shown that a 2-4 week diet with Optifast® will reduce liver volume, in preparation for surgery. Omega-3 (Ω-3) polyunsaturated fatty acids (PUFAs) have been suggested as a treatment for NAFLD. They have several potential mechanisms of action, the most important being to alter hepatic gene expression, thereby switching intracellular metabolism from lipogenesis and storage to fatty acid oxidation and catabolism. There is also evidence that they improve insulin sensitivity, are anti-inflammatory and reduce TNF levels lipogenesis thus offering several potential therapeutic mechanisms.

Conditions

• Obesity, Morbid
• Obesity
• NAFLD
• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega-3	3 gr/day of Omega-3
DIETARY_SUPPLEMENT	Very Low Calorie Diet	4 servings/day Optifast

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-07-01
• Completion: 2019-12-01
• First posted: 2017-04-28
• Last updated: 2018-03-22