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

Primary Purpose

Fatty Liver, Bariatric Surgery Candidate

Status
Unknown status
Phase
Early Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
2 capsules of Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)) per day
Sponsored by
Khoo Teck Puat Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fatty Liver focused on measuring omega 3, bariatric surgery, fatty liver, vlcd

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Khoo Teck Puat HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omega-3 Supplementation

Arm Description

Proof of Concept and Safety Study of 4 weeks of Omega-3 supplementation pre- Bariatric Surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 28, 2019
Last Updated
September 12, 2021
Sponsor
Khoo Teck Puat Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03972319
Brief Title
Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study
Acronym
OLIVER
Official Title
Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Khoo Teck Puat Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver, Bariatric Surgery Candidate
Keywords
omega 3, bariatric surgery, fatty liver, vlcd

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 Supplementation
Arm Type
Experimental
Arm Description
Proof of Concept and Safety Study of 4 weeks of Omega-3 supplementation pre- Bariatric Surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
2 capsules of Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)) per day
Intervention Description
4 weeks course of Omega-3 (2 capsules of Blackmores Omega Daily Concentrated Fish Oil per day
Primary Outcome Measure Information:
Title
Changes of Liver Volume Facilitating Access during Bariatric Surgery
Description
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.
Time Frame
After 4 weeks of Omega-3 supplement
Secondary Outcome Measure Information:
Title
Change in Biochemical parameters (serum ALT levels) of fatty liver disease
Description
To demonstrate changes in liver volume also translates to improved biochemical parameters (serum Alanine Aminotransferase levels) of fatty liver disease.
Time Frame
After 4 weeks of Omega-3 supplement
Title
Change in Biochemical parameters (serum AST levels) of fatty liver disease
Description
To demonstrate changes in liver volume also translates to improved biochemical parameters (serum Aspartate Aminotransferase levels) of fatty liver disease.
Time Frame
After 4 weeks of Omega-3 supplement
Title
Change in Biochemical parameters (serum Platelet levels) of fatty liver disease
Description
To demonstrate changes in liver volume also translates to improved biochemical parameters (serum Platelet levels) of fatty liver disease.
Time Frame
After 4 weeks of Omega-3 supplement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Ng, MBBS MMed
Phone
65558000
Email
ng.deborah.cy@ktph.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anton Cheng, MBBS FRCS
Organizational Affiliation
Khoo Teck Puat Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deborah Ng, MBBS MMed
Organizational Affiliation
Khoo Teck Puat Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tan Chun Hai, MBBS FRCS
Organizational Affiliation
Khoo Teck Puat Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lim Kheng Tian, MBBS FRCS
Organizational Affiliation
Khoo Teck Puat Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tan Bo Chuan, MBBS FRCS
Organizational Affiliation
Khoo Teck Puat Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Babu Suresh Balasubramaniam, MBBS FRCR
Organizational Affiliation
Khoo Teck Puat Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Khoo Teck Puat Hospital
City
Singapore
ZIP/Postal Code
587968
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Ng, MBBS MMed (Surg)

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23686653
Citation
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.
Results Reference
background
Links:
URL
http://ales.amegroups.com/article/download/4052/4885
Description
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

Learn more about this trial

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

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