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OpenTrials
Completed

NCT Number: NCT03587753

Experiment 2: Understanding 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oxford Centre for Diabetes, Endocrinology and Metabolism

Oxford, OX3 7LE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary fatty acid partitioning

Other

There is no intervention as such, just a physiological assessment of the partitioning and oxidation of two different types of dietary fatty acids

Primary outcomes

  1. Dietary fatty acid partitioning

    Time frame: 6 hours

    The appearance of the 13Clabelled fatty acid in plasma triglycerides

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

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

Acronym: FATOX

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2018
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.