Fatty LiverNCT03737071
The Effects of Low Carbohydrate Diet on Liver Fat Content and Mitochondrial Fluxes
A study testing Low Carbohydrate Diet and Simple Calorie Restriction Diet in people with Fatty Liver, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to examine whether a low carbohydrate diet as compared to simple calorie restriction decreases hepatic lipid content and changes hepatic mitochondrial flux in humans. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatty Liver
- What is being tested?
- Low Carbohydrate Diet and Simple Calorie Restriction Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- 15 Nov 2018to Aug 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70
- Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent
Who cannot join
- chronic liver disease other than NAFLD
- chronic disease associated with hepatic steatosis such as diabetes mellitus
- use of drugs known to affect hepatic steatosis
- contraindications for MRI
- pregnancy or nursing at the time of the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine whether a low carbohydrate diet as compared to simple calorie restriction decreases hepatic lipid content and changes hepatic mitochondrial flux in humans.
Read the detailed description
In this study, the investigators will examine whether a low carbohydrate diet as compared to simple calorie restriction will change hepatic lipid content and mitochondrial flux in humans. Before and after a low carbohydrate diet and a simple calorie restriction intervention, rates of hepatic mitochondrial flux will be assessed using positional isotopomer analysis of 3-13C-lactate during a 3 hour basal period. Rates of whole body ketogenesis will be determined using [13C4]β-hydroxybutyrate, and whole body glucose metabolism will be measured using [2H7]glucose. Body composition will be determined with bioelectrical impedance; hepatic lipid content will be measured with MRS. Whole-body oxidation of lipids, carbohydrates and protein will be determined using indirect calorimetry.
- Conditions
- Fatty Liver
- Being tested
- Low Carbohydrate Diet, Simple Calorie Restriction Diet
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Carbohydrate DietBehavioural
Ketogenic dietary intervention
Simple Calorie Restriction DietBehavioural
Simple calorie restriction dietary intervention
| Study group | Role | What they receive |
|---|---|---|
| Low Carbohydrate Diet | Experimental | Low Carbohydrate Diet Receives: Behavioral: Low Carbohydrate Diet |
| Simple Calorie Restriction Diet | Active comparator | Simple Calorie Restriction Diet Receives: Behavioral: Simple Calorie Restriction Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hepatic triglyceride content
Change in hepatic triglyceride content will be measured using 1H magnetic resonance spectroscopy (MRS).
Measured: 1 week
Change in hepatic mitochondrial flux
Change in the rate of hepatic mitochondrial flux (Vcs) will be assessed using 3-13C-lactate infusion.
Measured: 1 week
Secondary outcomes (2)
Change in beta-hydroxybutyrate production rate
Change in the rate of beta-hydroxybutyrate production will be assessed using [13C4]β-hydroxybutyrate infusion.
Measured: 1 week
Change in glucose production rate
Change in the rate of glucose production will be assessed using [2H7]glucose infusion.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start15 Nov 2018
- Primary completionJul 2024 (estimated)
- Study completionAug 2024 (estimated)
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 Fatty LiverStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Low Carbohydrate Diet versus Simple Calorie Restriction Diet
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panu Luukkonen, Helsinki University Central Hospital
- Investigators
- Panu Luukkonen, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737071
- Sponsor's protocol ID
- HUS21372018
- Status last verified
- Jul 2024
- First submitted
- 6 Nov 2018
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared as much as our ethics permission and the GDPR regulations of the European Union allow
Publications
Qadri SF, Porthan K, Dufour S, Lehtimaki TE, Petersen KF, Shulman GI, Yki-Jarvinen H, Luukkonen PK. Distinct effects of ketogenic and non-ketogenic weight-loss diets on hepatic steatosis and mitochondrial metabolism in MASLD. J Hepatol. 2026 Jul;85(1):26-36. doi: 10.1016/j.jhep.2026.02.001. Epub 2026 Feb 6.
PubMed 41655910
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low Carbohydrate Diet on Liver Fat Content and Mitochondrial Fluxes
- ClinicalTrials.gov ID
- NCT03737071
- Acronym / sponsor ID
- HUS21372018
- Conditions
- Fatty Liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 9 Nov 2018 (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 examine whether a low carbohydrate diet as compared to simple calorie restriction decreases hepatic lipid content and changes hepatic mitochondrial flux in humans.
Detailed description
In this study, the investigators will examine whether a low carbohydrate diet as compared to simple calorie restriction will change hepatic lipid content and mitochondrial flux in humans. Before and after a low carbohydrate diet and a simple calorie restriction intervention, rates of hepatic mitochondrial flux will be assessed using positional isotopomer analysis of 3-13C-lactate during a 3 hour basal period. Rates of whole body ketogenesis will be determined using [13C4]β-hydroxybutyrate, and whole body glucose metabolism will be measured using [2H7]glucose. Body composition will be determined with bioelectrical impedance; hepatic lipid content will be measured with MRS. Whole-body oxidation of lipids, carbohydrates and protein will be determined using indirect calorimetry.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Low Carbohydrate Diet versus Simple Calorie Restriction Diet
| Arm | Type | Receives |
|---|---|---|
| Low Carbohydrate Diet | Experimental | Behavioral: Low Carbohydrate DietLow Carbohydrate Diet |
| Simple Calorie Restriction Diet | Active comparator | Behavioral: Simple Calorie Restriction DietSimple Calorie Restriction Diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-70
- Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent
Key exclusion criteria (5 listed)
- chronic liver disease other than NAFLD
- chronic disease associated with hepatic steatosis such as diabetes mellitus
- use of drugs known to affect hepatic steatosis
- contraindications for MRI
- pregnancy or nursing at the time of the study
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 |
|---|---|---|
| Low Carbohydrate DietKetogenic dietary intervention | Behavioural | Low Carbohydrate Diet |
| Simple Calorie Restriction DietSimple calorie restriction dietary intervention | Behavioural | Simple Calorie Restriction Diet |
Primary outcome
Change in hepatic triglyceride content
Time frame: 1 week
Change in hepatic triglyceride content will be measured using 1H magnetic resonance spectroscopy (MRS).
Change in hepatic mitochondrial flux
Time frame: 1 week
Change in the rate of hepatic mitochondrial flux (Vcs) will be assessed using 3-13C-lactate infusion.
2 secondary outcomes
Change in beta-hydroxybutyrate production rate
Time frame: 1 week
Change in glucose production rate
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Derived from this study: PubMed 41655910Qadri SF, Porthan K, Dufour S, Lehtimaki TE, Petersen KF, Shulman GI, Yki-Jarvinen H, Luukkonen PK. Distinct effects of ketogenic and non-ketogenic weight-loss diets on hepatic steatosis and mitochondrial metabolism in MASLD. J Hepatol. 2026 Jul;85(1):26-36. doi: 10.1016/j.jhep.2026.02.001. Epub 2026 Feb 6.
- Individual participant dataSharing planned: No. IPD will be shared as much as our ethics permission and the GDPR regulations of the European Union allow
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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.
Panu Luukkonen principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Carbohydrate Diet and Simple Calorie Restriction Diet in people with Fatty Liver, run by Helsinki University Central Hospital at 1 site in Finland.
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 2 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: status not confirmed, as of the sponsor's last update on 24 Jul 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 Finland. 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?
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 hepatic triglyceride content (time frame: 1 week). The study lists 2 primary outcomes in all. 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 NCT03737071, 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 24 Jul 2024.