NCT03132662

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 22, 2018

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

April 3, 2017

Last Update Submit

March 20, 2018

Conditions

Obesity, MorbidObesityNAFLDNASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

  • Left liver lobe size

    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 Outcomes (2)

  • NAFLD

    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

    After the treatment period of 3 weeks, before bariatric surgery is completed

Study Arms (3)

Very Low Calorie Diet

ACTIVE COMPARATOR

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

Omega-3

EXPERIMENTAL

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

No-treatment

NO INTERVENTION

The third group will not receive treatment for liver size reduction prior to surgery.

Interventions

Omega-3DIETARY_SUPPLEMENT

3 gr/day of Omega-3

Omega-3
Very Low Calorie DietDIETARY_SUPPLEMENT

4 servings/day Optifast

Very Low Calorie Diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Bellentani S, Marino M. Epidemiology and natural history of non-alcoholic fatty liver disease (NAFLD). Ann Hepatol. 2009;8 Suppl 1:S4-8.

    PMID: 19381118BACKGROUND

  • Hui JM, Kench JG, Chitturi S, Sud A, Farrell GC, Byth K, Hall P, Khan M, George J. Long-term outcomes of cirrhosis in nonalcoholic steatohepatitis compared with hepatitis C. Hepatology. 2003 Aug;38(2):420-7. doi: 10.1053/jhep.2003.50320.

    PMID: 12883486BACKGROUND

  • Masterton GS, Plevris JN, Hayes PC. Review article: omega-3 fatty acids - a promising novel therapy for non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2010 Apr;31(7):679-92. doi: 10.1111/j.1365-2036.2010.04230.x.

    PMID: 20415840BACKGROUND

  • Parker HM, Johnson NA, Burdon CA, Cohn JS, O'Connor HT, George J. Omega-3 supplementation and non-alcoholic fatty liver disease: a systematic review and meta-analysis. J Hepatol. 2012 Apr;56(4):944-51. doi: 10.1016/j.jhep.2011.08.018. Epub 2011 Oct 21.

    PMID: 22023985BACKGROUND

  • Clarke SD. Nonalcoholic steatosis and steatohepatitis. I. Molecular mechanism for polyunsaturated fatty acid regulation of gene transcription. Am J Physiol Gastrointest Liver Physiol. 2001 Oct;281(4):G865-9. doi: 10.1152/ajpgi.2001.281.4.G865.

    PMID: 11557505BACKGROUND

  • Svegliati-Baroni G, Candelaresi C, Saccomanno S, Ferretti G, Bachetti T, Marzioni M, De Minicis S, Nobili L, Salzano R, Omenetti A, Pacetti D, Sigmund S, Benedetti A, Casini A. A model of insulin resistance and nonalcoholic steatohepatitis in rats: role of peroxisome proliferator-activated receptor-alpha and n-3 polyunsaturated fatty acid treatment on liver injury. Am J Pathol. 2006 Sep;169(3):846-60. doi: 10.2353/ajpath.2006.050953.

    PMID: 16936261BACKGROUND

  • Bellentani S, Saccoccio G, Masutti F, Croce LS, Brandi G, Sasso F, Cristanini G, Tiribelli C. Prevalence of and risk factors for hepatic steatosis in Northern Italy. Ann Intern Med. 2000 Jan 18;132(2):112-7. doi: 10.7326/0003-4819-132-2-200001180-00004.

    PMID: 10644271BACKGROUND

  • Lewis MC, Phillips ML, Slavotinek JP, Kow L, Thompson CH, Toouli J. Change in liver size and fat content after treatment with Optifast very low calorie diet. Obes Surg. 2006 Jun;16(6):697-701. doi: 10.1381/096089206777346682.

    PMID: 16756727BACKGROUND

  • Colles SL, Dixon JB, Marks P, Strauss BJ, O'Brien PE. Preoperative weight loss with a very-low-energy diet: quantitation of changes in liver and abdominal fat by serial imaging. Am J Clin Nutr. 2006 Aug;84(2):304-11. doi: 10.1093/ajcn/84.1.304.

    PMID: 16895876BACKGROUND

  • Cohen JC, Horton JD, Hobbs HH. Human fatty liver disease: old questions and new insights. Science. 2011 Jun 24;332(6037):1519-23. doi: 10.1126/science.1204265.

    PMID: 21700865BACKGROUND

  • Capanni M, Calella F, Biagini MR, Genise S, Raimondi L, Bedogni G, Svegliati-Baroni G, Sofi F, Milani S, Abbate R, Surrenti C, Casini A. Prolonged n-3 polyunsaturated fatty acid supplementation ameliorates hepatic steatosis in patients with non-alcoholic fatty liver disease: a pilot study. Aliment Pharmacol Ther. 2006 Apr 15;23(8):1143-51. doi: 10.1111/j.1365-2036.2006.02885.x.

    PMID: 16611275BACKGROUND

  • Spadaro L, Magliocco O, Spampinato D, Piro S, Oliveri C, Alagona C, Papa G, Rabuazzo AM, Purrello F. Effects of n-3 polyunsaturated fatty acids in subjects with nonalcoholic fatty liver disease. Dig Liver Dis. 2008 Mar;40(3):194-9. doi: 10.1016/j.dld.2007.10.003. Epub 2007 Dec 4.

    PMID: 18054848BACKGROUND

  • Iannelli A, Martini F, Schneck AS, Ghavami B, Baudin G, Anty R, Gugenheim J. Preoperative 4-week supplementation with omega-3 polyunsaturated fatty acids reduces liver volume and facilitates bariatric surgery in morbidly obese patients. Obes Surg. 2013 Nov;23(11):1761-5. doi: 10.1007/s11695-013-0942-y.

    PMID: 23686653BACKGROUND

MeSH Terms

Conditions

Obesity, MorbidObesityNon-alcoholic Fatty Liver Disease

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Dennis Hong, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Babak Katiraee, MD

CONTACT

(905) 522-1155bkatirae@stjoes.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2017

First Posted

April 28, 2017

Study Start

January 1, 2019

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

March 22, 2018

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share