Omega-3 vs Very Low Calorie Diet for Liver Size Reduction
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|ClinicalTrials.gov Identifier: NCT03132662|
Recruitment Status : Not yet recruiting
First Posted : April 28, 2017
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity, Morbid Obesity NAFLD NASH - Nonalcoholic Steatohepatitis||Dietary Supplement: Omega-3 Dietary Supplement: Very Low Calorie Diet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Trial of Omega-3 Polyunsaturated Fatty Acids vs a Very Low Calorie Liquid Diet for Liver Volume Reduction Prior to Bariatric Surgery|
|Estimated Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
Active Comparator: Very Low Calorie Diet
The first group will continue according to the standard bariatric preoperative protocol and will be assigned a VLCLD of 900 cal/day (Optifast ® 4 servings/day each containing: 225 cal + 0.35 g linolenic acid) for 2-3 weeks prior to surgery according to the surgeon's preferences.
Dietary Supplement: Very Low Calorie Diet
4 servings/day Optifast
The second group will be assigned to 3 gr. daily oral intake of Ω-3 PUFAs ((Oceano3 ® 1000 mg Krill Oil tabs (150 mg EPA + 90 mg DHA) 3 times a day) for 4 weeks with only regular dietary suggestions before surgery.
Dietary Supplement: Omega-3
3 gr/day of Omega-3
No Intervention: No-treatment
The third group will not receive treatment for liver size reduction prior to surgery.
- Left liver lobe size [ Time Frame: First ultrasound will be done before treatment. Second ultrasound will be done after the treatment period of 3 weeks, before bariatric surgery is completed ]Size measured by sonography in centimetres.
- NAFLD [ Time Frame: First ultrasound will be done before treatment. Second ultrasound will be done after the treatment period of 3 weeks, before bariatric surgery is completed ]Liver density measures of sonography
- Costs [ Time Frame: After the treatment period of 3 weeks, before bariatric surgery is completed ]Amount paid out of pocket by patient for treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132662
|Contact: Babak Katiraee, MD||(905) 522-1155 ext firstname.lastname@example.org|
|Principal Investigator:||Dennis Hong, MD||McMaster University|