NCT01936779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 6, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

2.6 years

First QC Date

September 2, 2013

Last Update Submit

January 4, 2017

Conditions

NAFLD

Keywords

plasma triglyceridesdietary fatliver fat metabolismhuman

Outcome Measures

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.

    Eight weeks

Secondary Outcomes (1)

  • Hepatic fatty acid partitioning

    Eight weeks

Study Arms (2)

Dietary supplement: fatty acid active

ACTIVE COMPARATOR

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

Dietary Supplement: Dietary supplement: fatty acid

Dietary supplement: fatty acid placebo

PLACEBO COMPARATOR

4g/day olive oil for 8 weeks

Dietary Supplement: Dietary supplement: fatty acid

Interventions

Dietary supplement: fatty acidDIETARY_SUPPLEMENT

Consumption of n-3 fatty acids for 8 weeks

Also known as: n-3 fatty acids (EPA and DHA)
Dietary supplement: fatty acid active

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Centre for Diabetes, Endocrinology and Metabolism

Oxford, OX3 7LE, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 32188593DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Fatty Acids, Omega-3Olive Oil

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Leanne Hodson, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2013

First Posted

September 6, 2013

Study Start

September 1, 2013

Primary Completion

April 1, 2016

Study Completion

August 1, 2016

Last Updated

January 5, 2017

Record last verified: 2017-01

Locations

GB(1)