The effect of omega-3 in non-alcoholic fatty liver disease

ISRCTN	ISRCTN81956288
DOI	https://doi.org/10.1186/ISRCTN81956288
Protocol serial number	7156
Sponsor	University of Nottingham (UK)
Funder	Association of Medical Research Charities (AMRC) - CORE

Submission date: 19/05/2010
Registration date: 19/05/2010
Last edited: 24/08/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Richard Johnston
Scientific

Nottingham University Hospital
Wolfson Digestive Diseases Centre
C Floor, South Block QMC
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom

Study information

Primary study design	Interventional
Study design	Single centre randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The effect of n-3 polyunsaturated fatty acid (PUFA) supplementation in patients with steatosis due to non-alcoholic fatty liver disease
Study objectives	Assess the effects of a 3 month PUFA supplementation versus placebo.
Ethics approval(s)	Nottingham Research and Ethics Committee 1, 11/03/2008, ref: 08/H0403/14
Health condition(s) or problem(s) studied	Topic: Metabolic and Endocrine; Subtopic: Metabolic and Endocrine (all Subtopics); Disease: Metabolic & Endocrine (not diabetes)
Intervention	58 patients with biopsy proven steatosis due to non-alcoholic fatty liver disease (NAFLD) will be randomised to 3.5 g n-3 polyunsaturated fatty acid (PUFA) or oleic enriched sunflower oil capsules for 3 months. Follow-up length: 3 months Study entry: registration and one or more randomisations
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Fructose, glucose
Primary outcome measure(s)	Hepatic steatosis as determined by magnetic resonance imaging (MRI) spectroscopy pre- and post-intervention Liver fat stores (MR spectroscopy), measured pre- and post-intervention
Key secondary outcome measure(s)	Measured pre- and post-intervention: 1. Liver biochemistry 2. Lipid profile 3. Insulin resistance 4. Blood pressure 5. Abdominal visceral fat 6. Inflammatory cytokine profile
Completion date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	58
Key inclusion criteria	1. Age greater than 18 years, either sex 2. Liver biopsy showing NAFLD
Key exclusion criteria	1. Excessive alcohol intake - greater than 21 units per week in men and greater than 14 in women 2. A further liver disease diagnosis 3. Poorly controlled diabetes - HbA1c greater than 8.0% 4. Pregnancy 5. Cirrhosis 6. Significant inflammation on liver biopsy - classified as a Brunt moderate or severe 7. Life expectancy of less than 2 years 8. Contraindications to MR scanning - pacemaker or metallic foreign body 9. Changes in the dose or initiation of lipid altering medication within the preceeding three months, such as statins, fibrates or systemic steroids 10. Use of n-3 PUFA supplements within the prior 4 months, an adequate washout period
Date of first enrolment	12/01/2009
Date of final enrolment	01/12/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Nottingham University Hospital

Nottingham
NG7 2UH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/08/2016: No publications found, verifying study status with principal investigator