HypertriglyceridaemiaFIFHNCT01577056
Postprandial Lipid Metabolism in Familial Hypercholesterolaemia:Effects of Fish Oils
A study testing Fish oil capsule and HMG Coenzyme reductase in people with Hypertriglyceridaemia and Familial Hypercholesterolaemia, run by The University of Western Australia at 1 site in Australia.
Trial summary
The purpose of this study is to determine whether fish oil supplementation is effective in the treatment of abnormal fat metabolism in subjects with elevated cholesterolaemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertriglyceridaemia, Familial Hypercholesterolaemia
- What is being tested?
- Fish oil capsule and HMG Coenzyme reductase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2012to Mar 2014
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with FH (genetically defined LDL-receptor mutation or Dutch score >8) on statin treatment only
- Hypertriglyceridaemia on a random blood sample (triglycerides >1.5mml/L)
Who cannot join
- Subjects with diabetes mellitus
- major systemic illness or use of steroids or other lipid-regulating drugs (such as niacin, fibrate and colesevelam)
- patients on hypocaloric diets or LDL apheresis; anaemia, haemorrhage and pregnancy.
Trial locations and contacts
1 site in 1 country.
Australia1 site
School of Medicine & Pharmacology,University of Western Australia
Perth, Western Australia, 6000
Dick Chan, PhD, 61-8-92240268, dick.chan@uwa.edu.au
About this study
Official title: Effect of Fish Oil Supplementation on Postprandial Lipid Metabolism in Familial Hypercholesterolaemia
The purpose of this study is to determine whether fish oil supplementation is effective in the treatment of abnormal fat metabolism in subjects with elevated cholesterolaemia.
Read the detailed description
The use of statin therapy in familial hypercholesterolaemia (FH) is known to reduce cardiovascular risk and is a first line recommendation, however, there is considerable residual risk predicted by the presence of fasting and post-prandial hypertriglyceridaemia.
This study will examine the effect of oral n-3 fatty acid ethyl esters supplementation (4g/day, Omacor) on postprandial hypertriglyceridaemia and post-prandial arterial function when administrated to FH patients at increased risk of cardiovascular disease due to their residual fasting hypertriglyceridaemia.
- Being tested
- Fish oil capsule, HMG Coenzyme reductase
- Keywords
- Familial hypercholesterolaemia, Postprandial dyslipidaemia, Fish oil treatment, Cardiovascular disease
- Medical subject headings
- Hypertriglyceridemia, Hyperlipoproteinemia Type II, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil capsuleDietary supplement
Also called Omacor
4g Omega capsule for 12 weeks
HMG Coenzyme reductaseDrug
Also called Statin
All FH subjects are on standard statin treatment during study period
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Active comparator | Not described Receives: Dietary Supplement: Fish oil capsule |
| Placebo | Placebo comparator | FH subjects with standard treatment (statin treatment) Receives: Drug: HMG Coenzyme reductase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial changes in triglyceride-rich lipoprotein concentrations
Incremental area-under-the-curve (AUC) for triglycerides, apoB-48 and retinyl palmitate
Measured: 12 weeks
Secondary outcomes (1)
Triglyceride-rich lipoprotein kinetics
Kinetic studies of apoB48 and apoB-100 kinetics
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertriglyceridaemiaStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Principal investigator, Dick C Chan, The University of Western Australia
- Investigators
- Dick Chan, Phd, Principal investigator, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577056
- Sponsor's protocol ID
- 1028883
- Other IDs
- NHMRC1028883
- Acronym
- FIFH
- Status last verified
- Apr 2012
- First submitted
- 10 Apr 2012
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ying Q, Chan DC, Pang J, Croyal M, Blanchard V, Krempf M, Watts GF. Effect of omega-3 fatty acid ethyl esters on postprandial arterial elasticity in patients with familial hypercholesterolemia. Clin Nutr ESPEN. 2023 Jun;55:174-177. doi: 10.1016/j.clnesp.2023.03.012. Epub 2023 Mar 21.
PubMed 37202042Chan DC, Pang J, Barrett PH, Sullivan DR, Mori TA, Burnett JR, van Bockxmeer FM, Watts GF. Effect of omega-3 fatty acid supplementation on arterial elasticity in patients with familial hypercholesterolaemia on statin therapy. Nutr Metab Cardiovasc Dis. 2016 Dec;26(12):1140-1145. doi: 10.1016/j.numecd.2016.07.012. Epub 2016 Aug 3.
PubMed 27614801Chan DC, Pang J, Barrett PH, Sullivan DR, Burnett JR, van Bockxmeer FM, Watts GF. omega-3 Fatty Acid Ethyl Esters Diminish Postprandial Lipemia in Familial Hypercholesterolemia. J Clin Endocrinol Metab. 2016 Oct;101(10):3732-3739. doi: 10.1210/jc.2016-2217. Epub 2016 Aug 4.
PubMed 27490922
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fish Oil Supplementation on Postprandial Lipid Metabolism in Familial Hypercholesterolaemia
- ClinicalTrials.gov ID
- NCT01577056
- Acronym / sponsor ID
- FIFH / 1028883
- Keywords
- Familial hypercholesterolaemia, Postprandial dyslipidaemia, Fish oil treatment, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 13 Apr 2012 (estimated)
- 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.
The purpose of this study is to determine whether fish oil supplementation is effective in the treatment of abnormal fat metabolism in subjects with elevated cholesterolaemia.
Detailed description
The use of statin therapy in familial hypercholesterolaemia (FH) is known to reduce cardiovascular risk and is a first line recommendation, however, there is considerable residual risk predicted by the presence of fasting and post-prandial hypertriglyceridaemia.
This study will examine the effect of oral n-3 fatty acid ethyl esters supplementation (4g/day, Omacor) on postprandial hypertriglyceridaemia and post-prandial arterial function when administrated to FH patients at increased risk of cardiovascular disease due to their residual fasting hypertriglyceridaemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish oil | Active comparator | Dietary Supplement: Fish oil capsule |
| Placebo | Placebo comparator | Drug: HMG Coenzyme reductaseFH subjects with standard treatment (statin treatment) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with FH (genetically defined LDL-receptor mutation or Dutch score >8) on statin treatment only
- Hypertriglyceridaemia on a random blood sample (triglycerides >1.5mml/L)
Key exclusion criteria (3 listed)
- Subjects with diabetes mellitus
- major systemic illness or use of steroids or other lipid-regulating drugs (such as niacin, fibrate and colesevelam)
- patients on hypocaloric diets or LDL apheresis; anaemia, haemorrhage and pregnancy.
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 |
|---|---|---|
| Fish oil capsuleAlso: Omacor4g Omega capsule for 12 weeks | Dietary supplement | Fish oil |
| HMG Coenzyme reductaseAlso: StatinAll FH subjects are on standard statin treatment during study period | Drug | Placebo |
Primary outcome
Postprandial changes in triglyceride-rich lipoprotein concentrations
Time frame: 12 weeks
Incremental area-under-the-curve (AUC) for triglycerides, apoB-48 and retinyl palmitate
1 secondary outcome
Triglyceride-rich lipoprotein kinetics
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2012.
- Derived from this study: PubMed 37202042Ying Q, Chan DC, Pang J, Croyal M, Blanchard V, Krempf M, Watts GF. Effect of omega-3 fatty acid ethyl esters on postprandial arterial elasticity in patients with familial hypercholesterolemia. Clin Nutr ESPEN. 2023 Jun;55:174-177. doi: 10.1016/j.clnesp.2023.03.012. Epub 2023 Mar 21.
- Derived from this study: PubMed 27614801Chan DC, Pang J, Barrett PH, Sullivan DR, Mori TA, Burnett JR, van Bockxmeer FM, Watts GF. Effect of omega-3 fatty acid supplementation on arterial elasticity in patients with familial hypercholesterolaemia on statin therapy. Nutr Metab Cardiovasc Dis. 2016 Dec;26(12):1140-1145. doi: 10.1016/j.numecd.2016.07.012. Epub 2016 Aug 3.
- Derived from this study: PubMed 27490922Chan DC, Pang J, Barrett PH, Sullivan DR, Burnett JR, van Bockxmeer FM, Watts GF. omega-3 Fatty Acid Ethyl Esters Diminish Postprandial Lipemia in Familial Hypercholesterolemia. J Clin Endocrinol Metab. 2016 Oct;101(10):3732-3739. doi: 10.1210/jc.2016-2217. Epub 2016 Aug 4.
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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.
Dick Chan, Phd principal investigator
The University of Western Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil capsule and HMG Coenzyme reductase in people with Hypertriglyceridaemia and Familial Hypercholesterolaemia, run by The University of Western Australia at 1 site in Australia.
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 2 inclusion and 3 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 13 Apr 2012. 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 Australia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Dick Chan, PhD (61-8-92240268, dick.chan@uwa.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial changes in triglyceride-rich lipoprotein concentrations (time frame: 12 weeks). 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 NCT01577056, which also lists 3 linked publications.
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 13 Apr 2012.