The Effect of n-3 Polyunsaturated Fatty Acid Supplements in Patients With Non-Alcoholic Fatty Liver Disease - Full Text View

Sponsored by:	Nottingham University Hospitals NHS Trust
Information provided by:	Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier:	NCT00819338

Purpose

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.

Condition	Intervention	Phase
Non-Alcoholic Fatty Liver Disease	Dietary Supplement: Efamax	Phase II

MedlinePlus related topics: Dietary Supplements Diets Liver Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of n-3 Polyunsaturated Fatty Acid Supplementation in Patients With Non-Alcoholic Fatty Liver Disease

Further study details as provided by Nottingham University Hospitals NHS Trust:

Primary Outcome Measures:

Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in plasma biochemistry, insulin resistance, lipids, inflammatory cytokines [ Time Frame: 3 months ] [ Designated as safety issue: No ]
change in liver saturated, monounsaturated and polyunsaturated fatty acid indexes as assessed by MR spectroscopy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
changes in blood pressure, abdominal obesity and anthropometry as assessed clinically and by MR spectroscopy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
changes in diet as assessed historically [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	58
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
polyunsaturated: Active Comparator 5g per day of polyunsaturated fatty acids (3.5g EPA and DHA).	Dietary Supplement: Efamax 5g daily as capsules for 3 months
monounsaturated: Placebo Comparator 5g a day of oleic enriched sunflower oil	Dietary Supplement: Efamax 5g daily as capsules for 3 months

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age greater than 18 years
Liver biopsy diagnosis of NAFLD

Exclusion Criteria:

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.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819338

Contacts

Contact: Richard D Johnston, MRCP	0044 (0115) 8231072	rjohnston75@doctors.org.uk
Contact: Ian A Macdonald, PhD	0044 (0115) 8230119	ian.macdonald@nottingham.ac.uk

Locations

United Kingdom
Wolfson Digestive Diseases Centre, University Hospital	Recruiting
Nottingham, United Kingdom, NG7 2UH
Sub-Investigator: Richard D Johnston, MRCP

Sponsors and Collaborators

Nottingham University Hospitals NHS Trust

Investigators

Study Chair:

Ian A Macdonald, PhD

Biomedical Sciences, University Hospital, Nottingham

More Information

No publications provided

Responsible Party:	University Hospital Nottingham ( Professor CJ Hawkey )
Study ID Numbers:	NottinghamNHST1, REC 08/H0403/14, R&D 08GA001
Study First Received:	January 8, 2009
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00819338 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee; United Kingdom: National Health Service

Keywords provided by Nottingham University Hospitals NHS Trust:

Non-alcoholic fatty liver disease
Polyunsaturated fatty acids
Omega-3

Study placed in the following topic categories:

Liver Diseases
Non-alcoholic Steatohepatitis (NASH)
Digestive System Diseases
Fatty Liver

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases
Fatty Liver

ClinicalTrials.gov processed this record on May 06, 2009