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

NCT03972319 | Unknown Early Phase 1

• 1 other identifier: OLIVER 1.3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fatty Liver; Bariatric Surgery Candidate

Keywords

omega 3; bariatric surgery; fatty liver; vlcd

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Biochemical parameters (serum ALT levels) of fatty liver disease

  After 4 weeks of Omega-3 supplement

• Change in Biochemical parameters (serum AST levels) of fatty liver disease

  After 4 weeks of Omega-3 supplement

• Change in Biochemical parameters (serum Platelet levels) of fatty liver disease

  After 4 weeks of Omega-3 supplement

Study Arms (1)

Omega-3 Supplementation

EXPERIMENTAL

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

Interventions

2 capsules of Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)) per day DIETARY_SUPPLEMENT

4 weeks course of Omega-3 (2 capsules of Blackmores Omega Daily Concentrated Fish Oil per day

Omega-3 Supplementation

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Khoo Teck Puat Hospital: lead

Study Sites (1)

Khoo Teck Puat Hospital

Singapore, 587968, Singapore

RECRUITING

Related Publications (1)

• 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: 23686653 BACKGROUND

Related 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

MeSH Terms

Conditions

Fatty Liver

Interventions

Eicosapentaenoic Acid; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Anton Cheng, MBBS FRCS

  Khoo Teck Puat Hospital

  PRINCIPAL INVESTIGATOR

• Deborah Ng, MBBS MMed

  Khoo Teck Puat Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Central Study Contacts

Deborah Ng, MBBS MMed

CONTACT

65558000; ng.deborah.cy@ktph.com.sg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 3, 2019
• Study Start: September 17, 2019
• Primary Completion: December 1, 2022
• Study Completion: April 1, 2023
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)