Clinical trial NCT03972319: Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study
Official title: Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Fatty Liver
Bariatric Surgery Candidate
Keywords: omega 3
bariatric surgery
fatty liver
vlcd
Lead sponsor: Khoo Teck Puat Hospital
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Changes of Liver Volume Facilitating Access during Bariatric Surgery
timeFrame: After 4 weeks of Omega-3 supplement
Secondary outcomes:
measure: Change in Biochemical parameters (serum ALT levels) of fatty liver disease
timeFrame: After 4 weeks of Omega-3 supplement
measure: Change in Biochemical parameters (serum AST levels) of fatty liver disease
timeFrame: After 4 weeks of Omega-3 supplement
measure: Change in Biochemical parameters (serum Platelet levels) of fatty liver disease
timeFrame: After 4 weeks of Omega-3 supplement
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Khoo Teck Puat Hospital
Study officials:
affiliation: Khoo Teck Puat Hospital
name: Anton Cheng, MBBS FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Khoo Teck Puat Hospital
name: Deborah Ng, MBBS MMed
role: PRINCIPAL_INVESTIGATOR
affiliation: Khoo Teck Puat Hospital
name: Tan Chun Hai, MBBS FRCS
role: STUDY_DIRECTOR
affiliation: Khoo Teck Puat Hospital
name: Lim Kheng Tian, MBBS FRCS
role: STUDY_DIRECTOR
affiliation: Khoo Teck Puat Hospital
name: Tan Bo Chuan, MBBS FRCS
role: STUDY_DIRECTOR
affiliation: Khoo Teck Puat Hospital
name: Babu Suresh Balasubramaniam, MBBS FRCR
role: STUDY_DIRECTOR
References:
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.