Fat; LiverNCT03145350
The Effect of a High-fat vs. High-sugar Diet on Liver Fat Accumulation and Metabolism
A study testing High-fat, low-carbohydrate and Low-fat, high-carbohydrate in people with Fat; Liver and NAFLD, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) is the most prevalent liver disease in the world. It is currently unclear why fat starts to accumulate in the liver, although both the amount and type of food consumed have been implicated. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fat; Liver, NAFLD
- What is being tested?
- High-fat, low-carbohydrate and Low-fat, high-carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to Mar 2020
- 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 30 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 >25 <35kg/m2
- No medical condition or relevant drug therapy known to affect liver, lipid or glucose metabolism
Who cannot join
- Age <30 or >65 years
- Body mass index <25 or >35kg/m2
- A blood haemoglobin <120mg/dL
- Any metabolic condition or relevant drug therapy
- People who do not tolerate fructose
- 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: The Effect of a High Fat Compared to a High Sugar Diet on Liver Fat Accumulation and Metabolism
Non-alcoholic fatty liver disease (NAFLD) is the most prevalent liver disease in the world. It is currently unclear why fat starts to accumulate in the liver, although both the amount and type of food consumed have been implicated. The majority of studies that have investigated the effects of dietary fat or sugar on liver fat have fed volunteers excess calories, which are known to increase liver fat. The effect of specific dietary components, when consumed as part of a diet not containing excess calories, on liver fat accumulation remains unclear.
Read the detailed description
This research aims to investigate the role excessive consumption of specific macronutrients may play in the development of NAFLD. This will be achieved by subjecting participants to two specific dietary interventions (high-fat, low-carbohydrate and low-fat, high-carbohydrate) in a randomized, crossover research design. Liver fat content, and whole-body and hepatic fasting and postprandial lipid metabolism will be assessed before and after the specific dietary interventions.
- Conditions
- Fat; Liver, NAFLD
- Being tested
- High-fat, low-carbohydrate, Low-fat, high-carbohydrate
- Keywords
- NAFLD, Fat intake, Sugar intake
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat, low-carbohydrateOther
Dietary intervention: 4 week
Low-fat, high-carbohydrateOther
Dietary intervention: 4 week
| Study group | Role | What they receive |
|---|---|---|
| High-fat, low-carbohydrate diet | Active comparator | Dietary intervention: Participants will consume a diet that is rich in saturated fat (20% total energy) and low in free sugars for 4 weeks. This diet will include commonly eaten foods such as butter, cheese, and fatty meat products. Total fat intake in this intervention will be 40-45% total energy. Receives: Other: High-fat, low-carbohydrate |
| Low-fat, high-carbohydrate diet | Active comparator | Dietary intervention: Participants will consume a diet that is low in saturated fat (~5% total energy) and rich in free sugars (20% total energy).The diet will include commonly eaten food and drink such as sugar sweetened beverages, confectionery (e.g. fruit gums) and table sugar. Receives: Other: Low-fat, high-carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver fat content
Investigators will measure the change in liver fat content after each of the 4 week intervention diets by magnetic resonance imaging/spectroscopy (MRI/S).
Measured: Before, and within 7 days after completion of each dietary intervention
Secondary outcomes (3)
Change in hepatic fatty acid partitioning
Investigators will utilise stable isotope tracer methodology to measure the contribution of newly synthesised fatty acids and dietary fatty acids to triglyceride production and oxidation pathways in the liver after each of the 4 week intervention diets.
Measured: Within 7 days after completion of each dietary intervention
Change in plasma metabolite concentrations
Circulating concentrations of glucose, insulin, non-esterified fatty acids, and triglycerides will be measured biochemically using a clinical analyser after each of the 4 week intervention diets.
Measured: Before, and within 7 days after completion of each dietary intervention.
Change in whole-body fatty acid oxidation
Investigators will utilise stable isotope tracer methodology to measure whole-body dietary fatty acid oxidation after each of the 4 week intervention diets.
Measured: Within 7 days after completion of each dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study startDec 2016
- Primary completionDec 2019
- Study completionMar 2020
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 Fat; LiverStudies 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 crossover with washout period.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 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
- NCT03145350
- Sponsor's protocol ID
- Oxlip-2017-HFD/HSD
- Status last verified
- May 2018
- First submitted
- 9 Jan 2017
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Following completion of the study, all individual data obtained from participants may potentially be shared with other researchers, both here in the United Kingdom and abroad, in appropriate circumstances. If data is to be shared with other researchers, it will be done so under fully anonymised conditions.
Publications
Parry SA, Rosqvist F, Mozes FE, Cornfield T, Hutchinson M, Piche ME, Hulsmeier AJ, Hornemann T, Dyson P, Hodson L. Intrahepatic Fat and Postprandial Glycemia Increase After Consumption of a Diet Enriched in Saturated Fat Compared With Free Sugars. Diabetes Care. 2020 May;43(5):1134-1141. doi: 10.2337/dc19-2331. Epub 2020 Mar 12.
PubMed 32165444
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a High Fat Compared to a High Sugar Diet on Liver Fat Accumulation and Metabolism
- ClinicalTrials.gov ID
- NCT03145350
- Acronym / sponsor ID
- Oxlip-2017-HFD/HSD
- Conditions
- Fat; Liver, NAFLD
- Keywords
- NAFLD, Fat intake, Sugar intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 9 May 2017 (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.
Non-alcoholic fatty liver disease (NAFLD) is the most prevalent liver disease in the world. It is currently unclear why fat starts to accumulate in the liver, although both the amount and type of food consumed have been implicated. The majority of studies that have investigated the effects of dietary fat or sugar on liver fat have fed volunteers excess calories, which are known to increase liver fat. The effect of specific dietary components, when consumed as part of a diet not containing excess calories, on liver fat accumulation remains unclear.
Detailed description
This research aims to investigate the role excessive consumption of specific macronutrients may play in the development of NAFLD. This will be achieved by subjecting participants to two specific dietary interventions (high-fat, low-carbohydrate and low-fat, high-carbohydrate) in a randomized, crossover research design. Liver fat content, and whole-body and hepatic fasting and postprandial lipid metabolism will be assessed before and after the specific dietary interventions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomised crossover with washout period.
| Arm | Type | Receives |
|---|---|---|
| High-fat, low-carbohydrate diet | Active comparator | Other: High-fat, low-carbohydrateDietary intervention: Participants will consume a diet that is rich in saturated fat (20% total energy) and low in free sugars for 4 weeks. This diet will include commonly eaten foods such as butter, cheese, and fatty meat products. Total fat intake in this intervention will be 40-45% total energy. |
| Low-fat, high-carbohydrate diet | Active comparator | Other: Low-fat, high-carbohydrateDietary intervention: Participants will consume a diet that is low in saturated fat (~5% total energy) and rich in free sugars (20% total energy).The diet will include commonly eaten food and drink such as sugar sweetened beverages, confectionery (e.g. fruit gums) and table sugar. |
Who may qualify
- Ages
- 30 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 >25 <35kg/m2
- No medical condition or relevant drug therapy known to affect liver, lipid or glucose metabolism
Key exclusion criteria (13 listed)
- Age <30 or >65 years
- Body mass index <25 or >35kg/m2
- A blood haemoglobin <120mg/dL
- Any metabolic condition or relevant drug therapy
- People who do not tolerate fructose
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 |
|---|---|---|
| High-fat, low-carbohydrateDietary intervention: 4 week | Other | High-fat, low-carbohydrate diet |
| Low-fat, high-carbohydrateDietary intervention: 4 week | Other | Low-fat, high-carbohydrate diet |
Primary outcome
Change in liver fat content
Time frame: Before, and within 7 days after completion of each dietary intervention
Investigators will measure the change in liver fat content after each of the 4 week intervention diets by magnetic resonance imaging/spectroscopy (MRI/S).
3 secondary outcomes
Change in hepatic fatty acid partitioning
Time frame: Within 7 days after completion of each dietary intervention
Change in plasma metabolite concentrations
Time frame: Before, and within 7 days after completion of each dietary intervention.
Change in whole-body fatty acid oxidation
Time frame: Within 7 days after completion of each dietary intervention
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 27 Mar 2020.
- Derived from this study: PubMed 32165444Parry SA, Rosqvist F, Mozes FE, Cornfield T, Hutchinson M, Piche ME, Hulsmeier AJ, Hornemann T, Dyson P, Hodson L. Intrahepatic Fat and Postprandial Glycemia Increase After Consumption of a Diet Enriched in Saturated Fat Compared With Free Sugars. Diabetes Care. 2020 May;43(5):1134-1141. doi: 10.2337/dc19-2331. Epub 2020 Mar 12.
- Individual participant dataSharing planned: Yes. Following completion of the study, all individual data obtained from participants may potentially be shared with other researchers, both here in the United Kingdom and abroad, in appropriate circumstances. If data is to be shared with other researchers, it will be done so under fully anonymised conditions.
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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.
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 High-fat, low-carbohydrate and Low-fat, high-carbohydrate in people with Fat; Liver and 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 27 Mar 2020. 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?
Change in liver fat content (time frame: Before, and within 7 days after completion of each dietary intervention). 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 NCT03145350, 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 27 Mar 2020.