NCT03118310

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

April 6, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

3.4 years

First QC Date

April 6, 2017

Last Update Submit

August 31, 2020

Conditions

NAFLD

Keywords

Reduction of liver fat

Outcome Measures

Primary Outcomes (1)

  • Liver fat

    MRI-measured liver fat content

    Three months

Study Arms (3)

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

5:2 dietBEHAVIORAL

Dietary intervention according to 5:2 diet during three months.

5:2
LCHFBEHAVIORAL

Dietary intervention according to LCHF diet during three months.

LCHF
Placebo dietBEHAVIORAL

Placebo diet: normal dietary advice

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Known NAFLD

You may not qualify if:

  • Other forms of liver disease
  • Bolus insulin treatment
  • Cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Digestive Diseases, Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 40797298DERIVED

  • Holmer 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.

    PMID: 33898960DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Diet

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Hannes Hagström, MD, PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 18, 2017

Study Start

April 6, 2017

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

September 2, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)