The Effect of n-3 Polyunsaturated Fatty Acid Supplements in Patients With Non-alcoholic Fatty Liver Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Omega-3 PUFA Supplementation in NAFLD Patients

NCT00230113

Non-Alcoholic Fatty Liver Disease

COMPLETED PHASE2

Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver

NCT00323414

Fatty Liver

COMPLETED PHASE2

The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease

NCT01277237

Non Alcoholic Fatty Liver Disease

COMPLETED PHASE3

Investigating the Effect of 4-week Omega-3 Polyunsaturated Fatty Acid Supplementation on Inflammation

NCT03210805

Healthy

UNKNOWN NA

Effect of Fish-oil on Non-alcoholic Steatohepatitis (NASH)

NCT01056133

Non-alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Non-alcoholic Fatty Liver Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

polyunsaturated

5g per day of polyunsaturated fatty acids (3.5g EPA and DHA).

Group Type ACTIVE_COMPARATOR

Efamax

Intervention Type DIETARY_SUPPLEMENT

5g daily as capsules for 3 months

monounsaturated

5g a day of oleic enriched sunflower oil

Group Type PLACEBO_COMPARATOR

Efamax

Intervention Type DIETARY_SUPPLEMENT

5g daily as capsules for 3 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Efamax

5g daily as capsules for 3 months

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

oleic enriched sunflower oil

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age greater than 18 years
2. Liver biopsy diagnosis of NAFLD

Exclusion Criteria

1. Excessive alcohol intake - \> 21 units per week in men and \> 14 in women
2. A further liver disease diagnosis
3. Poorly controlled diabetes - HbA1c \> 8.0%, or use of insulin sensitisers
4. Pregnancy
5. Cirrhosis
6. Contraindications to MR scanning - pacemaker or metallic foreign body etc.
7. Changes in the dose or initiation of lipid altering medication within the preceding three months, such as statins, fibrates or systemic steroids
8. Use of n-3 PUFA supplements within the prior 4 months, an adequate washout period
9. Significant co-morbid inflammatory illnesses as determined by research team

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No