Fatty LiverEarly Phase 1OLIVERNCT03972319
Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study
A Early Phase 1 study testing 2 capsules of Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)) per day in people with Fatty Liver and Bariatric Surgery Candidate, run by Khoo Teck Puat Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatty Liver, Bariatric Surgery Candidate
- What is being tested?
- 2 capsules of Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)) per day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 17 Sep 2019to Apr 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pre-existing liver disease
- Excessive alcohol consumption
- Prior history of allergy to omega-3 products, salmon or other- related products
- central obesity
- Pregnant
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Khoo Teck Puat Hospital
Singapore, 587968
Deborah Ng, MBBS MMed (Surg)
About this study
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].
Read more
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
Read the 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.
- Conditions
- Fatty Liver, Bariatric Surgery Candidate
- Being tested
- 2 capsules of Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)) per day
- Keywords
- omega 3, bariatric surgery, fatty liver, vlcd
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 capsules of Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)) per dayDietary supplement
4 weeks course of Omega-3 (2 capsules of Blackmores Omega Daily Concentrated Fish Oil per day
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 Supplementation | Experimental | Proof of Concept and Safety Study of 4 weeks of Omega-3 supplementation pre- Bariatric Surgery Receives: Dietary Supplement: 2 capsules of Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)) per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 4 weeks of Omega-3 supplement
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: After 4 weeks of Omega-3 supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start17 Sep 2019
- Primary completionDec 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khoo Teck Puat Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anton Cheng, MBBS FRCS, Principal investigator, Khoo Teck Puat HospitalDeborah Ng, MBBS MMed, Principal investigator, Khoo Teck Puat HospitalTan Chun Hai, MBBS FRCS, Study director, Khoo Teck Puat HospitalLim Kheng Tian, MBBS FRCS, Study director, Khoo Teck Puat HospitalTan Bo Chuan, MBBS FRCS, Study director, Khoo Teck Puat HospitalBabu Suresh Balasubramaniam, MBBS FRCR, Study director, Khoo Teck Puat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972319
- Sponsor's protocol ID
- OLIVER 1.3
- Acronym
- OLIVER
- Status last verified
- Sep 2021
- First submitted
- 28 May 2019
- Last updated
- 14 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23686653
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study
- ClinicalTrials.gov ID
- NCT03972319
- Acronym / sponsor ID
- OLIVER / OLIVER 1.3
- Conditions
- Fatty Liver, Bariatric Surgery Candidate
- Keywords
- omega 3, bariatric surgery, fatty liver, vlcd
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Khoo Teck Puat HospitalUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Supplementation | Experimental | Dietary Supplement: 2 capsules of Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)) per dayProof of Concept and Safety Study of 4 weeks of Omega-3 supplementation pre- Bariatric Surgery |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Pre-existing liver disease
- Excessive alcohol consumption
- Prior history of allergy to omega-3 products, salmon or other- related products
- central obesity
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 capsules of Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)) per day4 weeks course of Omega-3 (2 capsules of Blackmores Omega Daily Concentrated Fish Oil per day | Dietary supplement | Omega-3 Supplementation |
Primary outcome
Changes of Liver Volume Facilitating Access during Bariatric Surgery
Time frame: After 4 weeks of Omega-3 supplement
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.
3 secondary outcomes
Change in Biochemical parameters (serum ALT levels) of fatty liver disease
Time frame: After 4 weeks of Omega-3 supplement
Change in Biochemical parameters (serum AST levels) of fatty liver disease
Time frame: After 4 weeks of Omega-3 supplement
Change in Biochemical parameters (serum Platelet levels) of fatty liver disease
Time frame: After 4 weeks of Omega-3 supplement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Background: PubMed 23686653Iannelli 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.
- 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 surgeryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton Cheng, MBBS FRCS principal investigator
Khoo Teck Puat Hospital
Deborah Ng, MBBS MMed principal investigator
Khoo Teck Puat Hospital
Tan Chun Hai, MBBS FRCS study director
Khoo Teck Puat Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 2 capsules of Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)) per day in people with Fatty Liver and Bariatric Surgery Candidate, run by Khoo Teck Puat Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deborah Ng, MBBS MMed (65558000, ng.deborah.cy@ktph.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Liver Volume Facilitating Access during Bariatric Surgery (time frame: After 4 weeks of Omega-3 supplement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03972319, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021; AzTrials last refreshed its copy on 29 Oct 2026.