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

NAFLD Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936779
• Other study ID #: Oxlip-2013
• Status: Completed
• Phase: N/A
• First received: September 2, 2013
• Last updated: January 4, 2017
• Start date: September 2013
• Est. completion date: August 2016

Study information

• Verified date: January 2017
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• NAFLD

Intervention

Dietary Supplement:
• Dietary supplement: fatty acid
Consumption of n-3 fatty acids for 8 weeks
• Dietary supplement: fatty acid
Consumption of olive oil for 8 weeks.

Locations

Country	Name	City	State
United Kingdom	Oxford Centre for Diabetes, Endocrinology and Metabolism	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No