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

NCT ID: NCT01936779

Last Updated: 2017-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-08-31

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.

Conditions

NAFLD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Dietary supplement: fatty acid active

4g/day n-3 fatty acids for 8 weeks

Group Type: ACTIVE_COMPARATOR

Dietary supplement: fatty acid

Intervention Type: DIETARY_SUPPLEMENT

Consumption of n-3 fatty acids for 8 weeks

Dietary supplement: fatty acid placebo

4g/day olive oil for 8 weeks

Group Type: PLACEBO_COMPARATOR

Dietary supplement: fatty acid

Intervention Type: DIETARY_SUPPLEMENT

Consumption of olive oil for 8 weeks.

Interventions

Dietary supplement: fatty acid

Consumption of n-3 fatty acids for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement: fatty acid

Consumption of olive oil for 8 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

n-3 fatty acids (EPA and DHA); Olive oil

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leanne Hodson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Oxford Centre for Diabetes, Endocrinology and Metabolism

Oxford, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 32188593 (View on PubMed)

Other Identifiers

Oxlip-2013

Identifier Type: -

Identifier Source: org_study_id