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

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ClinicalTrials.gov Identifier: NCT01936779
Recruitment Status : Completed
First Posted : September 6, 2013
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Study Description
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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.

Condition or disease Intervention/treatment Phase
NAFLD Dietary Supplement: Dietary supplement: fatty acid Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
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.
Study Start Date : September 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dietary supplement: fatty acid active
4g/day n-3 fatty acids for 8 weeks
 Dietary Supplement: Dietary supplement: fatty acid
Consumption of n-3 fatty acids for 8 weeks
Other Name: n-3 fatty acids (EPA and DHA)
Placebo Comparator: Dietary supplement: fatty acid placebo
4g/day olive oil for 8 weeks
 Dietary Supplement: Dietary supplement: fatty acid
Consumption of olive oil for 8 weeks.
Other Name: Olive oil


Outcome Measures
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Primary Outcome Measures :
  1. Plasma triglyceride concentrations [ Time Frame: Eight weeks ]
    Investigators will measure plasma triglyceride concentrations at baseline and 8 weeks after taking n-3 fatty acids or a placebo.


Secondary Outcome Measures :
  1. Hepatic fatty acid partitioning [ Time Frame: Eight weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936779


Locations
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United Kingdom
Oxford Centre for Diabetes, Endocrinology and Metabolism
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Leanne Hodson, PhD University of Oxford
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01936779    
Other Study ID Numbers: Oxlip-2013
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Keywords provided by University of Oxford:
plasma triglycerides
dietary fat
liver fat metabolism
human