NCT00819338

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

1.2 years

First QC Date

January 8, 2009

Last Update Submit

July 3, 2012

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Non-alcoholic fatty liver diseasePolyunsaturated fatty acidsOmega-3

Outcome Measures

Primary Outcomes (1)

  • Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy

    3 months

Secondary Outcomes (7)

  • Serum liver function tests, lipids, free fatty acids

    3 months

  • Insulin resistance as assessed by HOMA-IR and Adipose Tissue Insulin Resistance Index

    3 months

  • Liver saturated, monounsaturated and polyunsaturated fatty acid indexes as assessed by MR spectroscopy

    3 months

  • Visceral obesity as quantified by MRI, and the adipose derived serum leptin and adiponectin

    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

    3 months

  • +2 more secondary outcomes

Study Arms (2)

polyunsaturated

ACTIVE COMPARATOR

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

Dietary Supplement: Efamax

monounsaturated

PLACEBO COMPARATOR

5g a day of oleic enriched sunflower oil

Dietary Supplement: Efamax

Interventions

EfamaxDIETARY_SUPPLEMENT

5g daily as capsules for 3 months

Also known as: oleic enriched sunflower oil
monounsaturatedpolyunsaturated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 18 years
  • Liver biopsy diagnosis of NAFLD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson Digestive Diseases Centre, University Hospital

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Ian A Macdonald, PhD

    Biomedical Sciences, University Hospital, Nottingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 9, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations

GB(1)