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

March 20, 2018 updated by: McMaster University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants must meet ALL of the following inclusion criteria:

  • Fulfilled criteria for bariatric surgery as coined by National Institutes of Health conference (a body mass index (BMI) of 40 or more, OR a BMI of 35 or more with a serious health problem linked to obesity, such as type 2 diabetes, heart disease, or sleep apnea)
  • Their age is ≥18 years and ≤70 years
  • Able and willing to give written consent
  • The patient is willing to perform the pre-operative tests required for this study.

Exclusion Criteria:

Participants who meet any of the following criteria at the time of the baseline visit are NOT eligible to be enrolled in this study:

  • Prior bariatric surgery
  • Patient must not have any acute or chronic alteration of liver function (i.e. cirrhosis, active or chronic hepatitis, congenital hepatic disease, etc.)
  • Prior hepatic surgery
  • Contra-indication to general anesthesia
  • Any medical condition, which in the judgement of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
  • Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)
  • Patients receiving medication that would alter hepatic function significantly.
  • Patients with ascites.
  • History of alcohol abuse: >3 standard drinks/day in men or >2 standard drinks/day in women (one standard drink being defined as 12 ounces of 5% beer, 5 ounces of 12% wine or 1.5 ounces of 40% liquor).
  • Patients consuming Ω-3 supplements on a regular basis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Experimental: Omega-3
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First ultrasound will be done before treatment. Second ultrasound will be done after the treatment period of 3 weeks, before bariatric surgery is completed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
First ultrasound will be done before treatment. Second ultrasound will be done after the treatment period of 3 weeks, before bariatric surgery is completed
Costs
Time Frame: After the treatment period of 3 weeks, before bariatric surgery is completed
Amount paid out of pocket by patient for treatment
After the treatment period of 3 weeks, before bariatric surgery is completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Neptune

Investigators

  • Principal Investigator: Dennis Hong, MD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 3, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJHH_2042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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