NAFLDLICARBNCT04581421
The Role of Dietary Carbohydrate and Fat Availability in the Regulation of Hepatic Lipid Content
A study testing High Carb Low Fat Diet and Low Carb High Fat Diet in people with NAFLD and Overweight and Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate dietary compositions effect on liverfat measured by magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- NAFLD, Overweight and Obesity, Metabolic Syndrome
- What is being tested?
- High Carb Low Fat Diet and Low Carb High Fat Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Dec 2020to 15 Jun 2022
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men being 18-50 years old.
- Overweight (BMI 25-35)
- Low to moderate physical activity level, defined as ≤ 1 weekly session of aerobic exercise.
- Non-smokers
- No use of medicine
Who cannot join
- Fasting blood glucose indicating overt diabetes (≥7 mmol/l)
- HbA1C >48 mmol/mol
- Fasting plasma triacylglycerol indicating dyslipidemia (≥2.2 mmol/l)
- FIB-4 score >1.45
- Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate dietary compositions effect on liverfat measured by magnetic resonance imaging.
Read the detailed description
Overweight but otherwise healthy men will be included in the study which is a randomized diet intervention study in a cross over design.
The study involves 2 intervention periods of 5 days each, during which the participant ingests two different types of experimental diet. Participants will in randomized order (determined by block randomization) ingest a diet with low carbohydrate and high fat content, and a diet with high carbohydrate and low fat content.
- Conditions
- NAFLD, Overweight and Obesity, Metabolic Syndrome, Diabetes
- Being tested
- High Carb Low Fat Diet, Low Carb High Fat Diet
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Overweight, Obesity, Metabolic Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Carb Low Fat DietOther
The participants will be randomized to a diet of low carb/ high fat og high carb/low fat
Low Carb High Fat DietOther
The participants will be randomized to a diet of low carb/ high fat og high carb/low fat
| Study group | Role | What they receive |
|---|---|---|
| High Carb first | Experimental | Not described Receives: Other: High Carb Low Fat Diet; Other: Low Carb High Fat Diet |
| Low Carb first | Experimental | Not described Receives: Other: High Carb Low Fat Diet; Other: Low Carb High Fat Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liverfat
The effect of high-carbohydrate/low-fat vs low-carbohydrate/high-fat diet on change in MRS determined liver fat.
Measured: (MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)
Secondary outcomes (4)
Glycogen
effect of the low-carbohydrate/high-fat intake and high-carbohydrate/low-fat intake on hepatic glycogen content measured by 7T 13C-MRS
Measured: (MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)
fasting hepatic glucose output
measured by Ra of glucose= (infusion rate of 6,6 2H2-glucose)/TTR
Measured: (Day 0 and Day 6 of the diet intervention)
fasting blood triacylglycerol concentration
Measured: (Day 0 and Day 6 of the diet intervention)
Insulin clearance determined during steady state insulin infusion
Measured: (Day 0 and Day 6 of the diet intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start3 Dec 2020
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
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.
- 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
- Randomized diet intervention study in a cross over design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Danish Research Centre for Magnetic Resonance
- Responsible party
- Principal investigator, Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581421
- Sponsor's protocol ID
- LICARB ID PhD010-19.
- Acronym
- LICARB
- Status last verified
- Jan 2024
- First submitted
- 25 Sep 2020
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
London A, Richter MM, Sjoberg KA, Wewer Albrechtsen NJ, Povazan M, Drici L, Schaufuss A, Madsen L, Oyen J, Madsbad S, Holst JJ, van Hall G, Siebner HR, Richter EA, Kiens B, Lundsgaard A, Bojsen-Moller KN. The impact of short-term eucaloric low- and high-carbohydrate diets on liver triacylglycerol content in males with overweight and obesity: a randomized crossover study. Am J Clin Nutr. 2024 Aug;120(2):283-293. doi: 10.1016/j.ajcnut.2024.06.006. Epub 2024 Jun 22.
PubMed 38914224
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dietary Carbohydrate and Fat Availability in the Regulation of Hepatic Lipid Content
- ClinicalTrials.gov ID
- NCT04581421
- Acronym / sponsor ID
- LICARB / LICARB ID PhD010-19.
- Conditions
- NAFLD, Overweight and Obesity, Metabolic Syndrome, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Danish Research Centre for Magnetic Resonance
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 9 Oct 2020 (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.
The purpose of this study is to investigate dietary compositions effect on liverfat measured by magnetic resonance imaging.
Detailed description
Overweight but otherwise healthy men will be included in the study which is a randomized diet intervention study in a cross over design.
The study involves 2 intervention periods of 5 days each, during which the participant ingests two different types of experimental diet. Participants will in randomized order (determined by block randomization) ingest a diet with low carbohydrate and high fat content, and a diet with high carbohydrate and low fat content.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized diet intervention study in a cross over design
| Arm | Type | Receives |
|---|---|---|
| High Carb first | Experimental | Other: High Carb Low Fat Diet, Other: Low Carb High Fat Diet |
| Low Carb first | Experimental | Other: High Carb Low Fat Diet, Other: Low Carb High Fat Diet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy men being 18-50 years old.
- Overweight (BMI 25-35)
- Low to moderate physical activity level, defined as ≤ 1 weekly session of aerobic exercise.
- Non-smokers
- No use of medicine
Key exclusion criteria (5 listed)
- Fasting blood glucose indicating overt diabetes (≥7 mmol/l)
- HbA1C >48 mmol/mol
- Fasting plasma triacylglycerol indicating dyslipidemia (≥2.2 mmol/l)
- FIB-4 score >1.45
- Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia.
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 Carb Low Fat DietThe participants will be randomized to a diet of low carb/ high fat og high carb/low fat | Other | High Carb first, Low Carb first |
| Low Carb High Fat DietThe participants will be randomized to a diet of low carb/ high fat og high carb/low fat | Other | High Carb first, Low Carb first |
Primary outcome
Liverfat
Time frame: (MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)
The effect of high-carbohydrate/low-fat vs low-carbohydrate/high-fat diet on change in MRS determined liver fat.
4 secondary outcomes
Glycogen
Time frame: (MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)
fasting hepatic glucose output
Time frame: (Day 0 and Day 6 of the diet intervention)
fasting blood triacylglycerol concentration
Time frame: (Day 0 and Day 6 of the diet intervention)
Insulin clearance determined during steady state insulin infusion
Time frame: (Day 0 and Day 6 of the diet 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 23 Jan 2024.
- Derived from this study: PubMed 38914224London A, Richter MM, Sjoberg KA, Wewer Albrechtsen NJ, Povazan M, Drici L, Schaufuss A, Madsen L, Oyen J, Madsbad S, Holst JJ, van Hall G, Siebner HR, Richter EA, Kiens B, Lundsgaard A, Bojsen-Moller KN. The impact of short-term eucaloric low- and high-carbohydrate diets on liver triacylglycerol content in males with overweight and obesity: a randomized crossover study. Am J Clin Nutr. 2024 Aug;120(2):283-293. doi: 10.1016/j.ajcnut.2024.06.006. Epub 2024 Jun 22.
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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 High Carb Low Fat Diet and Low Carb High Fat Diet in people with NAFLD and Overweight and Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
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 5 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 23 Jan 2024. 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 Denmark. 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?
Liverfat (time frame: (MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)). 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 NCT04581421, 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 23 Jan 2024.