NAFLDNCT01936779
Understanding the Role of Dietary Fatty Acids on Liver Fat Metabolism in Humans
A study testing Dietary supplement: fatty acid in people with NAFLD, run by University of Oxford at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD
- What is being tested?
- Dietary supplement: fatty acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Aug 2016
- 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.
- 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
- People allergic to fish / seafood or nuts
- Smoking
Show all 13Show fewer
- 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
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: 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.
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.
Read the detailed description
Investigators will recruit men and women with no medical condition or relevant drug therapy that affects liver fat 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.
- Conditions
- NAFLD
- Being tested
- Dietary supplement: fatty acid
- Keywords
- plasma triglycerides, dietary fat, liver fat metabolism, human
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement: fatty acidDietary supplement
Also called n-3 fatty acids (EPA and DHA)
Consumption of n-3 fatty acids for 8 weeks
Dietary supplement: fatty acidDietary supplement
Also called Olive oil
Consumption of olive oil for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement: fatty acid active | Active comparator | 4g/day n-3 fatty acids for 8 weeks Receives: Dietary Supplement: Dietary supplement: fatty acid |
| Dietary supplement: fatty acid placebo | Placebo comparator | 4g/day olive oil for 8 weeks Receives: Dietary Supplement: Dietary supplement: fatty acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma triglyceride concentrations
Investigators will measure plasma triglyceride concentrations at baseline and 8 weeks after taking n-3 fatty acids or a placebo.
Measured: Eight weeks
Secondary outcomes (1)
Hepatic fatty acid partitioning
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.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2016
- Study completionAug 2016
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 NAFLDStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leanne Hodson, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936779
- Sponsor's protocol ID
- Oxlip-2013
- Status last verified
- Jan 2017
- First submitted
- 2 Sep 2013
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Green CJ, Pramfalk C, Charlton CA, Gunn PJ, Cornfield T, Pavlides M, Karpe F, Hodson L. Hepatic de novo lipogenesis is suppressed and fat oxidation is increased by omega-3 fatty acids at the expense of glucose metabolism. BMJ Open Diabetes Res Care. 2020 Mar;8(1):e000871. doi: 10.1136/bmjdrc-2019-000871.
PubMed 32188593
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01936779
- Acronym / sponsor ID
- Oxlip-2013
- Conditions
- NAFLD
- Keywords
- plasma triglycerides, dietary fat, liver fat metabolism, human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 Sep 2013 (estimated)
- 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.
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.
Detailed description
Investigators will recruit men and women with no medical condition or relevant drug therapy that affects liver fat 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement: fatty acid active | Active comparator | Dietary Supplement: Dietary supplement: fatty acid4g/day n-3 fatty acids for 8 weeks |
| Dietary supplement: fatty acid placebo | Placebo comparator | Dietary Supplement: Dietary supplement: fatty acid4g/day olive oil for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 supplement: fatty acidAlso: n-3 fatty acids (EPA and DHA)Consumption of n-3 fatty acids for 8 weeks | Dietary supplement | Dietary supplement: fatty acid active |
| Dietary supplement: fatty acidAlso: Olive oilConsumption of olive oil for 8 weeks. | Dietary supplement | Dietary supplement: fatty acid placebo |
Primary outcome
Plasma triglyceride concentrations
Time frame: Eight weeks
Investigators will measure plasma triglyceride concentrations at baseline and 8 weeks after taking n-3 fatty acids or a placebo.
1 secondary outcome
Hepatic fatty acid partitioning
Time frame: Eight weeks
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 5 Jan 2017.
- Derived from this study: PubMed 32188593Green CJ, Pramfalk C, Charlton CA, Gunn PJ, Cornfield T, Pavlides M, Karpe F, Hodson L. Hepatic de novo lipogenesis is suppressed and fat oxidation is increased by omega-3 fatty acids at the expense of glucose metabolism. BMJ Open Diabetes Res Care. 2020 Mar;8(1):e000871. doi: 10.1136/bmjdrc-2019-000871.
Related trials for NAFLD
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
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.
Leanne Hodson, PhD principal investigator
University of Oxford
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 supplement: fatty acid in people with NAFLD, 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 3 inclusion and 13 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 5 Jan 2017. 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. Some participants in this study may receive a placebo. 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?
Plasma triglyceride concentrations (time frame: Eight weeks). 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 NCT01936779, 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 5 Jan 2017.