Experiment 2: Understanding Liver Fat Metabolism

Fatty Acid Oxidation Clinical Trial

— FATOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03587753
• Other study ID #: Oxlip-2013 sub amend
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: June 2022
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Acid Oxidation

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Oxford Centre for Diabetes, Endocrinology and Metabolism	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary fatty acid partitioning	The appearance of the 13Clabelled fatty acid in plasma triglycerides	6 hours