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

University of Oxford logo

University of Oxford

Status

Completed

Conditions

NAFLD

Treatments

Dietary Supplement: Dietary supplement: fatty acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01936779
Oxlip-2013

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups, including a placebo group

Dietary supplement: fatty acid active
Active Comparator group
Description:
4g/day n-3 fatty acids for 8 weeks
Treatment:
Dietary Supplement: Dietary supplement: fatty acid
Dietary Supplement: Dietary supplement: fatty acid
Dietary supplement: fatty acid placebo
Placebo Comparator group
Description:
4g/day olive oil for 8 weeks
Treatment:
Dietary Supplement: Dietary supplement: fatty acid
Dietary Supplement: Dietary supplement: fatty acid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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