Liver FatFOSNCT05962190
Short-term Fat Overfeeding on the Effects of Liver Metabolism
A study testing Diet in people with Liver Fat and Cardiac Function, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Despite work showing the overconsumption of saturated fatty acids (SFA) to be metabolically deleterious, debate continues about whether there is a link between SFA and cardiovascular disease risk. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Fat, Cardiac Function, Lipid Disorder
- What is being tested?
- Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2023to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- The participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged ≥18 or ≤65 years.
- Body Mass Index ≥19 ≤35 kg/m2
- No medical condition or relevant drug therapy that is known to affect liver or adipose tissue metabolism.
- Weight stable for the previous 3 months
Who cannot join
- The participant is unwilling or unable to give informed consent for participation in the study. - Aged ≤18 or ≥65 years
- Body Mass Index ≤19 or ≥35kg/m2
- Blood haemoglobin <135mg/dL for men and <120mg/dL for women
- Donated (or lost) ≥250 ml of blood in the previous two months.
- On a weight loss diet or have decreased their body weight by >5% in the previous 3 months.
- Have increased their body weight by >5% in the previous 3 months.
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- Any metabolic condition or relevant drug therapy
- Current smoker
- History of alcoholism or a greater than recommended alcohol intake (>30 g of alcohol daily for men and >20 g of alcohol daily for women)
- Haemorrhagic disorders
- Anticoagulant treatment
- History of albumin allergy
- 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, pacemakers, or are unwilling to remove any piercings
- History of an eating disorder or any other psychological condition that may affect the participant's ability to adhere to study intervention/experimental diets.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Centre for Diabetes, Endocrinology and Metabolism
Oxford, OX3 7LE
Leanne Hodson, 01865 857224, leanne.hodson@ocdem.ox.ac.uk
Leanne Hodson, PhD
About this study
Official title: The Effect of Short-term Overconsumption of Specific Dietary Nutrients on Liver and Adipose Tissue Metabolism.
Despite work showing the overconsumption of saturated fatty acids (SFA) to be metabolically deleterious, debate continues about whether there is a link between SFA and cardiovascular disease risk. To explore this, we are undertaking a human in vivo parallel-design study, comparing two isocaloric high-fat diets; one enriched with SFA and the other enriched with unsaturated fatty acids (UFAs), to determine the impact of dietary fat composition on postprandial metabolism, liver fat, cardiac fat and cardiac function.
Read the detailed description
The investigators will recruit men and women with no medical condition or relevant drug therapy that affects lipid, glucose or liver metabolism.
Purpose and design:
The investigators are asking the research question: "How does the amount and type of fat consumed, influence liver fat content, cardiac function and postprandial fatty acid and liver fat metabolism when someone is not gaining or losing body weight?"
To address this research question investigators want to undertake detail physiological studies, in a parallel dietary intervention, where individuals will have an MRI/S scans to assess liver fat, cardiac fat and cardiac function, along with a postprandial study day to assess how their metabolic response to a experimental test meal, before and then 28 days after consumption of a eucaloric, high fat intervention diet that will be either enriched in saturated or unsaturated fat.
- Conditions
- Liver Fat, Cardiac Function, Lipid Disorder, Adiposity
- Being tested
- Diet
- Medical subject headings
- Fatty Liver, Lipid Metabolism Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
High fat (~60% of total energy intake) diet enriched with either SFA or UFA
| Study group | Role | What they receive |
|---|---|---|
| High fat, high SFA | Experimental | ~60% of total energy is from fat, of which ~45% is from SFA, ~55% is from PUFA Receives: Behavioral: Diet |
| High fat, high UFA | Experimental | ~60% of total energy is from fat, of which ~25% is from SFA, ~75% from UFA Receives: Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat
Changes in intrahepatic triglyceride, as measured by MRI
Measured: Pre- and after approx 28 days of consuming interventional diet
Secondary outcomes (1)
Postprandial plasma biochemistry
Changes in postprandial plasma triglycerides, glucose, insulin over 6 hours following consumption of a standardized experimental test meal
Measured: Pre- and after approx 28 days of consuming interventional diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start15 Feb 2023
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FatStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
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
- NCT05962190
- Sponsor's protocol ID
- 211172
- Acronym
- FOS
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Short-term Overconsumption of Specific Dietary Nutrients on Liver and Adipose Tissue Metabolism.
- ClinicalTrials.gov ID
- NCT05962190
- Acronym / sponsor ID
- FOS / 211172
- Conditions
- Liver Fat, Cardiac Function, Lipid Disorder, Adiposity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 27 Jul 2023 (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.
Despite work showing the overconsumption of saturated fatty acids (SFA) to be metabolically deleterious, debate continues about whether there is a link between SFA and cardiovascular disease risk. To explore this, we are undertaking a human in vivo parallel-design study, comparing two isocaloric high-fat diets; one enriched with SFA and the other enriched with unsaturated fatty acids (UFAs), to determine the impact of dietary fat composition on postprandial metabolism, liver fat, cardiac fat and cardiac function.
Detailed description
The investigators will recruit men and women with no medical condition or relevant drug therapy that affects lipid, glucose or liver metabolism.
Purpose and design:
The investigators are asking the research question: "How does the amount and type of fat consumed, influence liver fat content, cardiac function and postprandial fatty acid and liver fat metabolism when someone is not gaining or losing body weight?"
To address this research question investigators want to undertake detail physiological studies, in a parallel dietary intervention, where individuals will have an MRI/S scans to assess liver fat, cardiac fat and cardiac function, along with a postprandial study day to assess how their metabolic response to a experimental test meal, before and then 28 days after consumption of a eucaloric, high fat intervention diet that will be either enriched in saturated or unsaturated fat.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fat, high SFA | Experimental | Behavioral: Diet~60% of total energy is from fat, of which ~45% is from SFA, ~55% is from PUFA |
| High fat, high UFA | Experimental | Behavioral: Diet~60% of total energy is from fat, of which ~25% is from SFA, ~75% from UFA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged ≥18 or ≤65 years.
- Body Mass Index ≥19 ≤35 kg/m2
- No medical condition or relevant drug therapy that is known to affect liver or adipose tissue metabolism.
- Weight stable for the previous 3 months
Key exclusion criteria (16 listed)
- The participant is unwilling or unable to give informed consent for participation in the study. - Aged ≤18 or ≥65 years
- Body Mass Index ≤19 or ≥35kg/m2
- Blood haemoglobin <135mg/dL for men and <120mg/dL for women
- Donated (or lost) ≥250 ml of blood in the previous two months.
- On a weight loss diet or have decreased their body weight by >5% in the previous 3 months.
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 |
|---|---|---|
| DietHigh fat (~60% of total energy intake) diet enriched with either SFA or UFA | Behavioural | High fat, high SFA, High fat, high UFA |
Primary outcome
Liver fat
Time frame: Pre- and after approx 28 days of consuming interventional diet
Changes in intrahepatic triglyceride, as measured by MRI
1 secondary outcome
Postprandial plasma biochemistry
Time frame: Pre- and after approx 28 days of consuming interventional diet
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- 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.
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 Diet in people with Liver Fat and Cardiac Function, 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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 27 Jul 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leanne Hodson (01865 857224, leanne.hodson@ocdem.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fat (time frame: Pre- and after approx 28 days of consuming interventional diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2023.