Understanding the Role of Dietary Fatty Acids on Liver Fat Metabolism in Humans

Not Applicable

Completed

• Conditions: NAFLD

• Registration Number: NCT01936779
• Lead Sponsor: University of Oxford

Brief Summary

High levels of fatty substances in the blood increase the risk of developing heart disease. Investigators know a lot about one of these fatty substances, cholesterol. However, there is another fatty substance in the blood called triglyceride. Investigators do not understand much about what regulates the rate at which the liver produces triglyceride and liberates it into the bloodstream after eating a meal(s). It is known that taking fish oil lowers the amount of blood triglyceride however, it remains unclear how this happens. Investigators will study if changes in liver fat metabolism, after taking fatty acids found in fish oil (n-3 fatty acids)can explain the lowering of blood triglyceride. Investigators also want to know if taking fish oil alters the amount of fat that accumulates within the liver.

Detailed Description

Investigators will recruit men and women with no medical condition or relevant drug therapy that affects liver fat metabolism.

Purpose and design:

Investigators are asking the research question: "How do specific fatty acids, such as those found in fish ((n-3) fatty acids) influence postprandial liver fat metabolism?"

It is known that n-3 fatty acids lower plasma triglyceride concentrations but it remains unclear how this happens.

To address this research question investigators want to undertake detail physiological studies, in a randomised study where individuals will be studied before and after taking n-3 fatty acids or a placebo oil.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-02
• Study First Posted: 2013-09-06
• Primary Completion: 2016-04
• Study Completion: 2016-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the study.
• BMI >19 <35kg/m2
• No medical condition or relevant drug therapy known to affect liver metabolism

Exclusion Criteria

• Age <18 or >65 years
• Body mass index <19 or >35kg/m2
• A blood haemoglobin <120mg/dL
• Any metabolic condition or relevant drug therapy
• People allergic to fish / seafood or nuts
• Smoking
• History of alcoholism or a greater than recommended alcohol intake
• Pregnant or nursing mothers
• Women prescribed any contraceptive agent or device including oral contraceptives, hormone replacement therapy (HRT) or who have used these within the last 12 months
• History of severe claustrophobia
• Presence of metallic implants, pacemaker
• Haemorrhagic disorders
• Anticoagulant treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Plasma triglyceride concentrations	Eight weeks	Investigators will measure plasma triglyceride concentrations at baseline and 8 weeks after taking n-3 fatty acids or a placebo.

Secondary Outcome Measures

Name	Time	Method
Hepatic fatty acid partitioning	Eight weeks	Investigators will measure the contribution of newly synthesised fatty acids and dietary fatty acids to triglyceride production and oxidation pathways in the liver at baseline and 8 weeks after taking n-3 fatty acids.

Trial Locations

Locations (1)

Oxford Centre for Diabetes, Endocrinology and Metabolism; 🇬🇧 Oxford, United Kingdom