Treatment of NAFLD With Two Different Diets | NCT03118310

Studies
Treatment of NAFLD With Two Different Diets

NCT03118310

Sponsor

Karolinska University Hospital

Status

Completed

Last Update Posted

Sep 2, 2020Actual

Enrollment

74Actual

Phase

Phase 2

Conditions

NAFLD

Interventions

5:2 diet
LCHF
Placebo diet

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 6, 2017Actual

Primary Completion Date

Aug 31, 2020Actual

Completion Date

Aug 31, 2020Actual

First Submitted Date

Apr 6, 2017

First Submission Date that Met QC Criteria

Apr 17, 2017

First Posted Date

Apr 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2020

Last Update Posted Date

Sep 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hannes Hagström, Primary Investigator, Karolinska University HospitalPrincipal Investigator

Lead Sponsor

Karolinska University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo diet	Behavioral: Placebo diet
5:2	Experimental	5:2 diet	Behavioral: 5:2 diet
LCHF	Experimental	LCHF diet	Behavioral: LCHF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
5:2 diet	Behavioral	Dietary intervention according to 5:2 diet during three months.	5:2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Liver fat	MRI-measured liver fat content	Three months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Known NAFLD

Exclusion Criteria:

Other forms of liver disease
Bolus insulin treatment
Cirrhosis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hannes Hagström, MD, PhD	Karolinska University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Digestive Diseases, Karolinska University Hospital		Stockholm		14186	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40797298	Derived	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.
33898960

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena