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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigating Intra-hepatic Fatty Acid Partitioning and Its Regulation in Man. Studies to Understand the Role of Dietary Nutrients in Liver Fat Metabolism in Relation to Obesity in Man.

Conditions
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NAFLD

Intervention / Treatment
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* Dietary Supplement: Dietary supplement: fatty acid
* Dietary Supplement: Dietary supplement: fatty acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dietary supplement: fatty acid active<br>4g/day n-3 fatty acids for 8 weeks | Dietary Supplement: Dietary supplement: fatty acid<br>* Consumption of n-3 fatty acids for 8 weeks<br>* Other names: n-3 fatty acids (EPA and DHA);|
| Placebo Comparator: Dietary supplement: fatty acid placebo<br>4g/day olive oil for 8 weeks | Dietary Supplement: Dietary supplement: fatty acid<br>* Consumption of olive oil for 8 weeks.<br>* Other names: Olive oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma triglyceride concentrations | Investigators will measure plasma triglyceride concentrations at baseline and 8 weeks after taking n-3 fatty acids or a placebo. | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic fatty acid partitioning | 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. | Eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plasma triglycerides, dietary fat, liver fat metabolism, human