Experiment 2: Understanding Liver Fat Metabolism (FATOX)

Understanding Liver Fat Metabolism: Studies to Understand the Role of Dietary Nutrients on Liver Fat Metabolism

There is a largely unsubstantiated thought in the literature that dietary unsaturated enter oxidation pathways preferentially compared to saturated fatty acids. This study is undertaking a direct comparison of the oxidation of dietary saturated and unsaturated fatty acids.

Study Overview

• Status: Completed
• Conditions: Fatty Acid Oxidation
• Intervention / Treatment: Other: Dietary fatty acid partitioning

Detailed Description

Provided subjects meet the inclusion criteria, then at least one week after the screening visit volunteers will then undertake the first two 'study days'. There will be two study days on separate occasions that will be up to 3 weeks apart. Each study day will be approximately 7 hours in duration. On each study day participants will be given a standardised 'test' meal that contains specially labelled fat molecules (stable-isotope tracer) and then repeated breath and blood samples will be taken over the course of the next 6 hours. The test meal consumed on each 'study day' will be identical in composition with only the specially labelled fat molecules being different (either unsaturated or saturated fat) and these will be given in a random order.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Participant is willing and able to give informed consent for participation in the study.

Male or Female, aged >18 and <65 years 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
  • Smoking
  • History of alcoholism or a greater than recommended alcohol intake
  • Pregnant or nursing mothers
  • Women prescribed hormone replacement therapy (HRT) or who have used this within the last 12 months
  • History of severe claustrophobia
  • Presence of metallic implants, pacemaker
  • Haemorrhagic disorders
  • Anticoagulant treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Unsaturated; A test meal containing a unsaturated fatty acid labelled with 13C to measure hepatic fatty acid partitioning.	Other: Dietary fatty acid partitioning; There is no intervention as such, just a physiological assessment of the partitioning and oxidation of two different types of dietary fatty acids
ACTIVE_COMPARATOR: Saturated; A test meal containing a saturated fatty acid labelled with 13C to measure hepatic fatty acid partitioning	Other: Dietary fatty acid partitioning; There is no intervention as such, just a physiological assessment of the partitioning and oxidation of two different types of dietary fatty acids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary fatty acid partitioning	The appearance of the 13Clabelled fatty acid in plasma triglycerides	6 hours

Collaborators and Investigators

• Sponsor: University of Oxford

Publications and helpful links

General Publications

• Parry SA, Rosqvist F, Cornfield T, Barrett A, Hodson L. Oxidation of dietary linoleate occurs to a greater extent than dietary palmitate in vivo in humans. Clin Nutr. 2021 Mar;40(3):1108-1114. doi: 10.1016/j.clnu.2020.07.013. Epub 2020 Jul 22.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2018
• Primary Completion (ACTUAL): January 1, 2021
• Study Completion (ACTUAL): January 1, 2021

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (ACTUAL): July 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Oxlip-2013 sub amend

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No