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

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.

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.

Study Overview

• Status: Completed
• Conditions: NAFLD
• Intervention / Treatment: Dietary supplement: Dietary supplement: fatty acid; Dietary supplement: Dietary supplement: fatty acid

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 7LE
    • Oxford Centre for Diabetes, Endocrinology and Metabolism

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Leanne Hodson, PhD, University of Oxford

Publications and helpful links

General Publications

• Green CJ, Pramfalk C, Charlton CA, Gunn PJ, Cornfield T, Pavlides M, Karpe F, Hodson L. Hepatic de novo lipogenesis is suppressed and fat oxidation is increased by omega-3 fatty acids at the expense of glucose metabolism. BMJ Open Diabetes Res Care. 2020 Mar;8(1):e000871. doi: 10.1136/bmjdrc-2019-000871.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: September 2, 2013
• First Submitted That Met QC Criteria: September 2, 2013
• First Posted (Estimate): September 6, 2013

Study Record Updates

• Last Update Posted (Estimate): January 5, 2017
• Last Update Submitted That Met QC Criteria: January 4, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: human; plasma triglycerides; dietary fat; liver fat metabolism
• Other Study ID Numbers: Oxlip-2013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No