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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
Sponsor:
Collaborator:
Neptune
Information provided by (Responsible Party):
McMaster University

Brief 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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Costs [ Time Frame: After the treatment period of 3 weeks, before bariatric surgery is completed ]
    Amount paid out of pocket by patient for treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Babak Katiraee, MD (905) 522-1155 ext 35842 bkatirae@stjoes.ca

Sponsors and Collaborators
McMaster University
Neptune
Investigators
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Principal Investigator: Dennis Hong, MD McMaster University

Publications:

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03132662     History of Changes
Other Study ID Numbers: SJHH_2042
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Obesity
Fatty Liver
Non-alcoholic Fatty Liver Disease
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Liver Diseases
Digestive System Diseases