Fatty Acid OxidationFATOXNCT03587753
Experiment 2: Understanding Liver Fat Metabolism
A study testing Dietary fatty acid partitioning in people with Fatty Acid Oxidation, run by University of Oxford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatty Acid Oxidation
- What is being tested?
- Dietary fatty acid partitioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2018to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Centre for Diabetes, Endocrinology and Metabolism
Oxford, OX3 7LE
About this study
Official title: 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.
Read the 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.
- Conditions
- Fatty Acid Oxidation
- Being tested
- Dietary fatty acid partitioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary fatty acid partitioningOther
There is no intervention as such, just a physiological assessment of the partitioning and oxidation of two different types of dietary fatty acids
| Study group | Role | What they receive |
|---|---|---|
| Unsaturated | Active comparator | A test meal containing a unsaturated fatty acid labelled with 13C to measure hepatic fatty acid partitioning. Receives: Other: Dietary fatty acid partitioning |
| Saturated | Active comparator | A test meal containing a saturated fatty acid labelled with 13C to measure hepatic fatty acid partitioning Receives: Other: Dietary fatty acid partitioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary fatty acid partitioning
The appearance of the 13Clabelled fatty acid in plasma triglycerides
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start1 May 2018
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fatty Acid OxidationStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised cross-over
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587753
- Sponsor's protocol ID
- Oxlip-2013 sub amend
- Acronym
- FATOX
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2018
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32753348
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Liver Fat Metabolism: Studies to Understand the Role of Dietary Nutrients on Liver Fat Metabolism
- ClinicalTrials.gov ID
- NCT03587753
- Acronym / sponsor ID
- FATOX / Oxlip-2013 sub amend
- Conditions
- Fatty Acid Oxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 16 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomised cross-over
| Arm | Type | Receives |
|---|---|---|
| Unsaturated | Active comparator | Other: Dietary fatty acid partitioningA test meal containing a unsaturated fatty acid labelled with 13C to measure hepatic fatty acid partitioning. |
| Saturated | Active comparator | Other: Dietary fatty acid partitioningA test meal containing a saturated fatty acid labelled with 13C to measure hepatic fatty acid partitioning |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- • Age <18 or >65 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary fatty acid partitioningThere is no intervention as such, just a physiological assessment of the partitioning and oxidation of two different types of dietary fatty acids | Other | Saturated, Unsaturated |
Primary outcome
Dietary fatty acid partitioning
Time frame: 6 hours
The appearance of the 13Clabelled fatty acid in plasma triglycerides
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Derived from this study: PubMed 32753348Parry 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary fatty acid partitioning in people with Fatty Acid Oxidation, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary fatty acid partitioning (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03587753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.