Non-alcoholic Fatty Liver DiseasePhase 2NCT00819338
The Effect of n-3 Polyunsaturated Fatty Acid Supplements in Patients With Non-alcoholic Fatty Liver Disease
A Phase 2 study testing Efamax in people with Non-alcoholic Fatty Liver Disease, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The principal purpose of this study is to determine whether increased intakes of n-3 polyunsaturated (omega-3) fatty acids will reduce the amount of fat stored in the liver in patients with non-alcoholic fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Efamax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Mar 2010
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Liver biopsy diagnosis of NAFLD
Who cannot join
- Excessive alcohol intake - > 21 units per week in men and > 14 in women
- A further liver disease diagnosis
- Poorly controlled diabetes - HbA1c > 8.0%, or use of insulin sensitisers
- Pregnancy
- Cirrhosis
- Contraindications to MR scanning - pacemaker or metallic foreign body etc.
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- Changes in the dose or initiation of lipid altering medication within the preceding three months, such as statins, fibrates or systemic steroids
- Use of n-3 PUFA supplements within the prior 4 months, an adequate washout period
- Significant co-morbid inflammatory illnesses as determined by research team
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wolfson Digestive Diseases Centre, University Hospital
Nottingham, NG7 2UH
About this study
Official title: The Effect of n-3 Polyunsaturated Fatty Acid Supplementation in Patients With Non-alcoholic Fatty Liver Disease
The principal purpose of this study is to determine whether increased intakes of n-3 polyunsaturated (omega-3) fatty acids will reduce the amount of fat stored in the liver in patients with non-alcoholic fatty liver disease.
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is present in 10-24% of the general adult population. The first step of NAFLD involves the accumulation of fat within the liver (steatosis). Steatosis occurs either due to defective generation, metabolism or excretion of fatty acids by the liver. The next step in NAFLD progression is inflammation, which commonly occurs due to pro-inflammatory stimuli. Persistent inflammation results in end-stage liver disease. NAFLD is associated with the metabolic syndrome, which is characterised by central obesity, insulin resistance, raised triglycerides and hypertension. With the current obesity epidemic, there is predicted to be greater numbers of patients with NAFLD in the future.
Polyunsaturated fatty acids (PUFAs) are essential components of our diet, though standard Western intakes are lower than the recommended amounts. Supplementing the long chain n-3 PUFAs (commonly termed omega-3), EPA and DHA, improves many of the metabolic syndrome features. They lower plasma triglycerides, and may improve insulin resistance.
The diet of NAFLD patients tends to be deficient in n-3 PUFAs and have an excessive intake of the harmful n-6 PUFAs. This pattern is mirrored in their liver lipid content as assessed at biopsy.
Currently there is no proven treatment for NAFLD. Animal studies and limited studies in patients have been supportive of a benefit with n-3 polyunsaturated fatty acids. This needs to be further assessed.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Efamax
- Keywords
- Non-alcoholic fatty liver disease, Polyunsaturated fatty acids, Omega-3
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfamaxDietary supplement
Also called oleic enriched sunflower oil
5g daily as capsules for 3 months
| Study group | Role | What they receive |
|---|---|---|
| polyunsaturated | Active comparator | 5g per day of polyunsaturated fatty acids (3.5g EPA and DHA). Receives: Dietary Supplement: Efamax |
| monounsaturated | Placebo comparator | 5g a day of oleic enriched sunflower oil Receives: Dietary Supplement: Efamax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy
Measured: 3 months
Secondary outcomes (7)
Serum liver function tests, lipids, free fatty acids
Measured: 3 months
Insulin resistance as assessed by HOMA-IR and Adipose Tissue Insulin Resistance Index
Measured: 3 months
Liver saturated, monounsaturated and polyunsaturated fatty acid indexes as assessed by MR spectroscopy
Measured: 3 months
Visceral obesity as quantified by MRI, and the adipose derived serum leptin and adiponectin
Measured: 3 months
Primary assessment of the fibrotic and inflammatory status of the liver with serum TGF beta, TNF a, IL-6, IL-8, IL-8, IL-10
Measured: 3 months
Further informative cytokine analyses: GM-CSF, IFN-G, IL-1B, IL-1RA, IL-2, IL-4, IL-5, MCP1
Measured: 3 months
Compliance assessed by serum phospholipid fatty acids
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Johnston, University of Nottingham
- Investigators
- Ian A Macdonald, PhD, Study chair, Biomedical Sciences, University Hospital, Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819338
- Sponsor's protocol ID
- NottinghamNHST1
- Other IDs
- REC 08/H0403/14, R&D 08GA001
- Status last verified
- Jul 2012
- First submitted
- 8 Jan 2009
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of n-3 Polyunsaturated Fatty Acid Supplementation in Patients With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT00819338
- Acronym / sponsor ID
- NottinghamNHST1
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Non-alcoholic fatty liver disease, Polyunsaturated fatty acids, Omega-3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 Jan 2009 (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 principal purpose of this study is to determine whether increased intakes of n-3 polyunsaturated (omega-3) fatty acids will reduce the amount of fat stored in the liver in patients with non-alcoholic fatty liver disease.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is present in 10-24% of the general adult population. The first step of NAFLD involves the accumulation of fat within the liver (steatosis). Steatosis occurs either due to defective generation, metabolism or excretion of fatty acids by the liver. The next step in NAFLD progression is inflammation, which commonly occurs due to pro-inflammatory stimuli. Persistent inflammation results in end-stage liver disease. NAFLD is associated with the metabolic syndrome, which is characterised by central obesity, insulin resistance, raised triglycerides and hypertension. With the current obesity epidemic, there is predicted to be greater numbers of patients with NAFLD in the future.
Polyunsaturated fatty acids (PUFAs) are essential components of our diet, though standard Western intakes are lower than the recommended amounts. Supplementing the long chain n-3 PUFAs (commonly termed omega-3), EPA and DHA, improves many of the metabolic syndrome features. They lower plasma triglycerides, and may improve insulin resistance.
The diet of NAFLD patients tends to be deficient in n-3 PUFAs and have an excessive intake of the harmful n-6 PUFAs. This pattern is mirrored in their liver lipid content as assessed at biopsy.
Currently there is no proven treatment for NAFLD. Animal studies and limited studies in patients have been supportive of a benefit with n-3 polyunsaturated fatty acids. This needs to be further assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polyunsaturated | Active comparator | Dietary Supplement: Efamax5g per day of polyunsaturated fatty acids (3.5g EPA and DHA). |
| monounsaturated | Placebo comparator | Dietary Supplement: Efamax5g a day of oleic enriched sunflower oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than 18 years
- Liver biopsy diagnosis of NAFLD
Key exclusion criteria (9 listed)
- Excessive alcohol intake - > 21 units per week in men and > 14 in women
- A further liver disease diagnosis
- Poorly controlled diabetes - HbA1c > 8.0%, or use of insulin sensitisers
- Pregnancy
- Cirrhosis
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 |
|---|---|---|
| EfamaxAlso: oleic enriched sunflower oil5g daily as capsules for 3 months | Dietary supplement | monounsaturated, polyunsaturated |
Primary outcome
Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy
Time frame: 3 months
7 secondary outcomes
Serum liver function tests, lipids, free fatty acids
Time frame: 3 months
Insulin resistance as assessed by HOMA-IR and Adipose Tissue Insulin Resistance Index
Time frame: 3 months
Liver saturated, monounsaturated and polyunsaturated fatty acid indexes as assessed by MR spectroscopy
Time frame: 3 months
Visceral obesity as quantified by MRI, and the adipose derived serum leptin and adiponectin
Time frame: 3 months
Primary assessment of the fibrotic and inflammatory status of the liver with serum TGF beta, TNF a, IL-6, IL-8, IL-8, IL-10
Time frame: 3 months
Further informative cytokine analyses: GM-CSF, IFN-G, IL-1B, IL-1RA, IL-2, IL-4, IL-5, MCP1
Time frame: 3 months
Compliance assessed by serum phospholipid fatty acids
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2012.
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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.
Ian A Macdonald, PhD study chair
Biomedical Sciences, University Hospital, Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efamax in people with Non-alcoholic Fatty Liver Disease, run by University of Nottingham at 1 site in United Kingdom.
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 9 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: finished, as of the sponsor's last update on 4 Jul 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 United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jul 2012.