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CompletedNCT01936779Updated Jan 5, 2017

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

An interventional study of Dietary supplement: fatty acid and Dietary supplement: fatty acid in NAFLD, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-05.

Sponsored by University of Oxford · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • NAFLD

Keywords

  • plasma triglycerides
  • dietary fat
  • liver fat metabolism
  • human
03

In context

Lead sponsor

University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Dietary supplement: fatty acid active

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

    Dietary Supplement: Dietary supplement: fatty acid

  • Placebo comparator
    Dietary supplement: fatty acid placebo

    4g/day olive oil for 8 weeks

    Dietary Supplement: Dietary supplement: fatty acid

Interventions

  • Dietary supplementDietary supplement: fatty acid

    Consumption of n-3 fatty acids for 8 weeks

    Also known as: n-3 fatty acids (EPA and DHA)

  • Dietary supplementDietary supplement: fatty acid

    Consumption of olive oil for 8 weeks.

    Also known as: Olive oil

06

What researchers measure

Primary outcomes

  1. Plasma triglyceride concentrations

    Investigators will measure plasma triglyceride concentrations at baseline and 8 weeks after taking n-3 fatty acids or a placebo.

    Time frame: Eight weeks

Secondary outcomes

  1. 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.

    Time frame: Eight weeks

07

Study locations

1 site
  • Oxford Centre for Diabetes, Endocrinology and Metabolism
    Oxford, OX3 7LE, United Kingdom
08

References and documents

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. PubMed 32188593 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01936779
Lead sponsor
University of Oxford
Responsible party
Sponsor
First posted
Sep 6, 2013
Start date
Sep 2013
Primary completion
Apr 2016
Completion
Aug 2016
Last update
Jan 5, 2017

Study contacts

Leanne Hodson, PhD
principal investigator · University of Oxford

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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