The effect of omega-3 in non-alcoholic fatty liver disease
Not Applicable
Completed
- Conditions
- Topic: Metabolic and EndocrineSubtopic: Metabolic and Endocrine (all Subtopics)Disease: Metabolic & Endocrine (not diabetes)Digestive SystemNon-alcoholic fatty liver disease
- Registration Number
- ISRCTN81956288
- Lead Sponsor
- niversity of Nottingham (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
1. Age greater than 18 years, either sex
2. Liver biopsy showing NAFLD
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hepatic steatosis as determined by magnetic resonance imaging (MRI) spectroscopy pre- and post-intervention<br>Liver fat stores (MR spectroscopy), measured pre- and post-intervention
- Secondary Outcome Measures
Name Time Method Measured pre- and post-intervention:<br>1. Liver biochemistry<br>2. Lipid profile<br>3. Insulin resistance<br>4. Blood pressure<br>5. Abdominal visceral fat<br>6. Inflammatory cytokine profile