NAFLDPhase 2TRENDNCT03118310
Treatment of NAFLD With Two Different Diets
A Phase 2 study testing 5:2 diet and LCHF in people with NAFLD, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The impact of popular diets on liver-related health is unclear. In this randomized, controlled trial, patients with NAFLD will be randomized to one of two popular diets or a placebo diet. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- NAFLD
- What is being tested?
- 5:2 diet and LCHF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSweden
- Study dates
- 6 Apr 2017to 31 Aug 2020
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Known NAFLD
Who cannot join
- Other forms of liver disease
- Bolus insulin treatment
- Cirrhosis
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Center for Digestive Diseases, Karolinska University Hospital
Stockholm, 14186
About this study
The impact of popular diets on liver-related health is unclear. In this randomized, controlled trial, patients with NAFLD will be randomized to one of two popular diets or a placebo diet.
Read the detailed description
Subjects will include patients with MRI-verified NAFLD, with no concurrent liver diseases. Randomization will be done to either a control diet, the 5:2 diet or a low-carb-high-fat diet. The subjects will follow the diet for three months, after which a new MRI is performed. Main outcomes measure is reduction in liver fat.
- Conditions
- NAFLD
- Being tested
- 5:2 diet, LCHF, Placebo diet
- Keywords
- Reduction of liver fat
- 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.
5:2 dietBehavioural
Dietary intervention according to 5:2 diet during three months.
LCHFBehavioural
Dietary intervention according to LCHF diet during three months.
Placebo dietBehavioural
Placebo diet: normal dietary advice
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo diet Receives: Behavioral: Placebo diet |
| 5:2 | Experimental | 5:2 diet Receives: Behavioral: 5:2 diet |
| LCHF | Experimental | LCHF diet Receives: Behavioral: LCHF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat
MRI-measured liver fat content
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start6 Apr 2017
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Karolinska University 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannes Hagström, Karolinska University Hospital
- Investigators
- Hannes Hagström, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118310
- Sponsor's protocol ID
- Dnr 2017/258-31
- Acronym
- TREND
- Status last verified
- Aug 2020
- First submitted
- 6 Apr 2017
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holmer M, Hagstrom H, Tillander V, Alkadri M, Petersson S, Brismar TB, Stal P, Lindqvist C. One-year follow-up of short-term dietary intervention for MASLD: sustained improvements in steatosis, weight and dietary intake. Scand J Gastroenterol. 2025 Nov;60(11):1087-1095. doi: 10.1080/00365521.2025.2544305. Epub 2025 Aug 12.
PubMed 40797298Holmer M, Lindqvist C, Petersson S, Moshtaghi-Svensson J, Tillander V, Brismar TB, Hagstrom H, Stal P. Treatment of NAFLD with intermittent calorie restriction or low-carb high-fat diet - a randomised controlled trial. JHEP Rep. 2021 Feb 17;3(3):100256. doi: 10.1016/j.jhepr.2021.100256. eCollection 2021 Jun.
PubMed 33898960
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of NAFLD With Two Different Diets
- ClinicalTrials.gov ID
- NCT03118310
- Acronym / sponsor ID
- TREND / Dnr 2017/258-31
- Conditions
- NAFLD
- Keywords
- Reduction of liver fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 18 Apr 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.
The impact of popular diets on liver-related health is unclear. In this randomized, controlled trial, patients with NAFLD will be randomized to one of two popular diets or a placebo diet.
Detailed description
Subjects will include patients with MRI-verified NAFLD, with no concurrent liver diseases. Randomization will be done to either a control diet, the 5:2 diet or a low-carb-high-fat diet. The subjects will follow the diet for three months, after which a new MRI is performed. Main outcomes measure is reduction in liver fat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Behavioral: Placebo dietPlacebo diet |
| 5:2 | Experimental | Behavioral: 5:2 diet5:2 diet |
| LCHF | Experimental | Behavioral: LCHFLCHF diet |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Known NAFLD
Key exclusion criteria (3 listed)
- Other forms of liver disease
- Bolus insulin treatment
- Cirrhosis
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 |
|---|---|---|
| 5:2 dietDietary intervention according to 5:2 diet during three months. | Behavioural | 5:2 |
| LCHFDietary intervention according to LCHF diet during three months. | Behavioural | LCHF |
| Placebo dietPlacebo diet: normal dietary advice | Behavioural | Placebo |
Primary outcome
Liver fat
Time frame: Three months
MRI-measured liver fat content
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 2 Sep 2020.
- Derived from this study: PubMed 40797298Holmer M, Hagstrom H, Tillander V, Alkadri M, Petersson S, Brismar TB, Stal P, Lindqvist C. One-year follow-up of short-term dietary intervention for MASLD: sustained improvements in steatosis, weight and dietary intake. Scand J Gastroenterol. 2025 Nov;60(11):1087-1095. doi: 10.1080/00365521.2025.2544305. Epub 2025 Aug 12.
- Derived from this study: PubMed 33898960Holmer M, Lindqvist C, Petersson S, Moshtaghi-Svensson J, Tillander V, Brismar TB, Hagstrom H, Stal P. Treatment of NAFLD with intermittent calorie restriction or low-carb high-fat diet - a randomised controlled trial. JHEP Rep. 2021 Feb 17;3(3):100256. doi: 10.1016/j.jhepr.2021.100256. eCollection 2021 Jun.
- 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. This study is not recruiting at the moment.
Hannes Hagström, MD, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5:2 diet and LCHF in people with NAFLD, run by Karolinska University Hospital at 1 site in Sweden.
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 1 inclusion and 3 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 2 Sep 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 Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Liver fat (time frame: Three months). 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 NCT03118310, which also lists 2 linked publications.
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 2 Sep 2020.