NAFLDNCT03090347
Effects of Dietary Nutrients on Liver and Adipose Tissue Metabolism
A study testing Overconsumption of specific dietary nutrient in people with NAFLD and Nutrient; Excess, run by University of Oxford at 1 site in United Kingdom.
Trial summary
In health,adipose tissue stores fat from the diet. If the fat tissue stops storing dietary fat then this increases the chance of it being stored in the liver, which is related to increased risk of heart disease and type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD, Nutrient; Excess
- What is being tested?
- Overconsumption of specific dietary nutrient
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2017to 31 Mar 2023
- 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 or ≤65 years.
- Body Mass Index ≥19 ≤35 kg/m2
- No medical condition or relevant drug therapy known to affect liver or adipose tissue metabolism.
- Weight stable for the previous 3 months
Who cannot join
- Patient is unwilling or unable to give informed consent for participation in the study
- A 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.
- Any metabolic condition or relevant drug therapy
Show all 16Show fewer
- 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 who are taking 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, or are unwilling to remove any piercings
- History of an eating disorder or any other psychological condition that may affect the participants ability to adhere to study intervention/experimental diets.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Centre for Diabetes, Endocrinology and Metabolism
Oxford, OX3 7LE
Louise Dennis, MSc, +441865 857 203, louise.dennis@ocdem.ox.ac.uk
Rachel Craven-Todd, +441865857331, rachel.craven-todd@ocdem.ox.ac.uk
About this study
Official title: The Effect of Short-term Overconsumption of Specific Dietary Nutrients on Liver and Adipose Tissue Metabolism
In health,adipose tissue stores fat from the diet. If the fat tissue stops storing dietary fat then this increases the chance of it being stored in the liver, which is related to increased risk of heart disease and type 2 diabetes. It has been suggested that having a diet high in sugars or certain fats, may cause the fat tissue and liver to change how they function; we would like to investigate this in detail.
Read the detailed description
This research aims to investigate how the overconsumption of specific macronutrients may effect adipose tissue and liver metabolism and function. Liver and heart fat content and adipose tissue and liver metabolism fasting and postprandial lipid metabolism will be assessed before and after the specific dietary intervention.
- Conditions
- NAFLD, Nutrient; Excess
- Being tested
- Overconsumption of specific dietary nutrient
- 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.
Overconsumption of specific dietary nutrientOther
Subjects will be studied before and then after the consumption of a diet where specific nutrients are provided in excess.
| Study group | Role | What they receive |
|---|---|---|
| High-sugar diet | Experimental | Participants will be asked to consume a relatively low-fat, high-carbohydrate eucaloric diet enriched in free-sugars (20% total energy). Receives: Other: Overconsumption of specific dietary nutrient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver de novo lipogenesis
Investigators will utilise stable isotope tracer methodology to measure the change in the contribution of newly synthesised fatty acids to very low density lipoprotein triglyceride
Measured: Within 21 days after starting the intervention diet
Secondary outcomes (2)
Adipose tissue metabolism
Investigators will measure the change in the expression of key lipogenic genes in subcutaneous adipose tissue
Measured: Within 21 days after starting the intervention diet
Liver fat accumulation
Investigators will measure the change in the amount of fat within the liver using MRI/S
Measured: Within 21 days after starting the intervention diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Mar 2017
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090347
- Sponsor's protocol ID
- Oxlip-2017-BBSRC/BHF
- Status last verified
- Apr 2022
- First submitted
- 20 Mar 2017
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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.
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
- The Effect of Short-term Overconsumption of Specific Dietary Nutrients on Liver and Adipose Tissue Metabolism
- ClinicalTrials.gov ID
- NCT03090347
- Acronym / sponsor ID
- Oxlip-2017-BBSRC/BHF
- Conditions
- NAFLD, Nutrient; Excess
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 24 Mar 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.
In health,adipose tissue stores fat from the diet. If the fat tissue stops storing dietary fat then this increases the chance of it being stored in the liver, which is related to increased risk of heart disease and type 2 diabetes. It has been suggested that having a diet high in sugars or certain fats, may cause the fat tissue and liver to change how they function; we would like to investigate this in detail.
Detailed description
This research aims to investigate how the overconsumption of specific macronutrients may effect adipose tissue and liver metabolism and function. Liver and heart fat content and adipose tissue and liver metabolism fasting and postprandial lipid metabolism will be assessed before and after the specific dietary intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-sugar diet | Experimental | Other: Overconsumption of specific dietary nutrientParticipants will be asked to consume a relatively low-fat, high-carbohydrate eucaloric diet enriched in free-sugars (20% total energy). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 known to affect liver or adipose tissue metabolism.
- Weight stable for the previous 3 months
Key exclusion criteria (16 listed)
- Patient is unwilling or unable to give informed consent for participation in the study
- A 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.
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 |
|---|---|---|
| Overconsumption of specific dietary nutrientSubjects will be studied before and then after the consumption of a diet where specific nutrients are provided in excess. | Other | High-sugar diet |
Primary outcome
Liver de novo lipogenesis
Time frame: Within 21 days after starting the intervention diet
Investigators will utilise stable isotope tracer methodology to measure the change in the contribution of newly synthesised fatty acids to very low density lipoprotein triglyceride
2 secondary outcomes
Adipose tissue metabolism
Time frame: Within 21 days after starting the intervention diet
Liver fat accumulation
Time frame: Within 21 days after starting the intervention diet
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- 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.
Related trials for NAFLD
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overconsumption of specific dietary nutrient in people with NAFLD and Nutrient; Excess, 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leanne Hodson, PhD (+441865857224, 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 de novo lipogenesis (time frame: Within 21 days after starting the intervention 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 7 Jun 2022.