Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study (OLIVER)

Omega-3 has been postulated to reduce hepatic steatosis by reducing lipogenic gene expression, exerting anti- inflammation action, reducing oxidative stress and improving glycemic control.

A recent meta-analysis by Parker et al.[1] found that omega-3 supplementation is associated with improvement in liver fat content as well as on Aspartate Aminotransferase (AST) levels. Omega-3 supplementation has also found to be useful in reducing blood triglyceride levels [2].

Recent studies by Iannelli et al. (2013) and Abidin et al.(2017) have also found that a 1 month supplementation of 1.5g/day and 2g/day of omega-3 supplementation resulted in reduced hepatic volume of 20% and 34.88 cm3 respectively.

The investigator's hypothesis is that a 4 weeks course of Omega-3 (2 capsules of Blackmores Omega Daily Concentrated Fish Oil per day; Each capsule Concentrated omega-3 triglycerides- fish 1000mg containing Omega-3 Marine Triglycerides 600mg as: 360mg Eicosapentaenoic acid (EPA), 240mg Docosahexaenoic acid (DHA)) taken as supplement, without any other dietary intervention pre Bariatric Surgery decreases significantly liver volume and facilitate access during surgery. And that shrinkage of liver volume also translates to improve biochemical parameters of fatty liver disease

Study Overview

• Status: Recruiting
• Conditions: Fatty Liver; Bariatric Surgery Candidate
• Intervention / Treatment: Dietary supplement: 2 capsules of Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)) per day

Detailed Description

A total of 50 subjects booked for Bariatric Surgery with BMI up 45 will be recruited. Patients with pre-existing liver disease, excessive alcohol consumption and significant central obesity will be excluded.

Ultrasound examination of the liver with liver volume measurement, and blood tests, including Liver Function Tests (LFT) and platelet counts,is performed as part of the pre surgery work up.

The subjects are then given 4 weeks of Omega-3 supplements (2 capsules of Blackmores Omega Daily Concentrated Fish Oil per day: Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)).

Just before Surgery, a repeat of ultrasound examination and measurement of liver volume is carried out, as well as a repeat liver panel and platelet count.The subjects will have their weight and body composition recorded as well at this time.

At the time of the surgery, the surgeon makes a subjective assessment of the left lobe liver volume on a scale of 1 to 5, 5 being the largest. Additionally,ease of access to area under the left lobe of the liver is also subjectively assessed, on a scale of 1 to5, 5 being the most difficult.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Deborah Ng, MBBS MMed; Phone Number: 65558000; Email: ng.deborah.cy@ktph.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 587968
    • Recruiting
    • Khoo Teck Puat Hospital
    • Contact: Deborah Ng, MBBS MMed (Surg)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects qualifying and scheduled for Bariatric Surgery (as according to Singapore Health Promotion Board- Ministry of Health Obesity Clinical Practice GuidelineJune 2016)
• BMI <45 with no significant central obesity.
• Has no pre-existing liver disease, or excess alcohol consumption.

Exclusion Criteria:

• Pre-existing liver disease
• Excessive alcohol consumption
• Prior history of allergy to omega-3 products, salmon or other- related products
• central obesity
• Pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Omega-3 Supplementation; Proof of Concept and Safety Study of 4 weeks of Omega-3 supplementation pre- Bariatric Surgery	Dietary supplement: 2 capsules of Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)) per day; 4 weeks course of Omega-3 (2 capsules of Blackmores Omega Daily Concentrated Fish Oil per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Liver Volume Facilitating Access during Bariatric Surgery	To demonstrate that Omega-3 oil taken as supplement, without any other dietary intervention pre Bariatric Surgery significantly changes liver volume and facilitates access during surgery.	After 4 weeks of Omega-3 supplement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Biochemical parameters (serum ALT levels) of fatty liver disease	To demonstrate changes in liver volume also translates to improved biochemical parameters (serum Alanine Aminotransferase levels) of fatty liver disease.	After 4 weeks of Omega-3 supplement
Change in Biochemical parameters (serum AST levels) of fatty liver disease	To demonstrate changes in liver volume also translates to improved biochemical parameters (serum Aspartate Aminotransferase levels) of fatty liver disease.	After 4 weeks of Omega-3 supplement
Change in Biochemical parameters (serum Platelet levels) of fatty liver disease	To demonstrate changes in liver volume also translates to improved biochemical parameters (serum Platelet levels) of fatty liver disease.	After 4 weeks of Omega-3 supplement

Collaborators and Investigators

• Sponsor: Khoo Teck Puat Hospital
• Investigators: Principal Investigator: Anton Cheng, MBBS FRCS, Khoo Teck Puat Hospital; Principal Investigator: Deborah Ng, MBBS MMed, Khoo Teck Puat Hospital; Study Director: Tan Chun Hai, MBBS FRCS, Khoo Teck Puat Hospital; Study Director: Lim Kheng Tian, MBBS FRCS, Khoo Teck Puat Hospital; Study Director: Tan Bo Chuan, MBBS FRCS, Khoo Teck Puat Hospital; Study Director: Babu Suresh Balasubramaniam, MBBS FRCR, Khoo Teck Puat Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

• A randomised controlled trial comparing the use of omega-3 polyunsaturated fatty acid supplements versus very low calorie dietary restriction in obese Malaysian patients awaiting bariatric surgery

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 17, 2019
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): April 1, 2023

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (ACTUAL): June 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 12, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: bariatric surgery; omega 3; fatty liver; vlcd
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: OLIVER 1.3

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