Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7156
Study information
Scientific title
The effect of n-3 polyunsaturated fatty acid (PUFA) supplementation in patients with steatosis due to non-alcoholic fatty liver disease
Acronym
Study hypothesis
Assess the effects of a 3 month PUFA supplementation versus placebo.
Ethics approval
Nottingham Research and Ethics Committee 1, 11/03/2008, ref: 08/H0403/14
Study design
Single centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Fructose, glucose
Primary outcome measures
Hepatic steatosis as determined by magnetic resonance imaging (MRI) spectroscopy pre- and post-intervention
Liver fat stores (MR spectroscopy), measured pre- and post-intervention
Secondary outcome measures
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
Overall trial start date
12/01/2009
Overall trial end date
01/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age greater than 18 years, either sex
2. Liver biopsy showing NAFLD
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 58; UK sample size: 58
Participant 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
Recruitment start date
12/01/2009
Recruitment end date
01/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nottingham University Hospital
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
Wolfson Digestive Diseases Centre
South Block
C-Floor
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Association of Medical Research Charities (AMRC) - CORE
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary