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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Oxford
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01936779
First received: September 2, 2013
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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 Intervention
Postprandial Hepatic Fatty Acid Metabolism
Dietary Supplement: Dietary supplement: fatty acid
Dietary Supplement: Dietary fatty acid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Plasma triglyceride concentrations [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    Investigators will measure plasma triglyceride concentrations at baseline and 8 weeks after taking n-3 fatty acids or a placebo.


Secondary Outcome Measures:
  • Hepatic fatty acid partitioning [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: September 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dietary supplement: fatty acid active
4g/day n-3 fatty acids for 8 weeks
Dietary Supplement: Dietary supplement: fatty acid
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 fatty acid
Other Name: Olive oil

Detailed Description:

Investigators will recruit men and women with no medical condition or relevant drug therapy that affects liver 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936779

Contacts
Contact: Leanne Hodson, PhD +441865 857 225 leanne.hodson@ocdem.ox.ac.uk
Contact: Emma Hoornaert, BA +441865 857 216 emma.hoornaert@ocdem.ox.ac.uk

Locations
United Kingdom
Oxford Centre for Diabetes, Endocrinology and Metabolism Recruiting
Oxford, United Kingdom, OX3 7LE
Contact: Louise Dennis, MSc    +441865 857 203    louise.dennis@ocdem.ox.ac.uk   
Principal Investigator: Leanne Hodson, PhD         
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Leanne Hodson, PhD University of Oxford
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01936779     History of Changes
Other Study ID Numbers: Oxlip-2013
Study First Received: September 2, 2013
Last Updated: September 6, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
plasma triglycerides
dietary fat
liver fat metabolism
human

ClinicalTrials.gov processed this record on July 29, 2014