Treatment of NAFLD With Two Different Diets

NCT ID: NCT03118310

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-06

Study Completion Date

2020-08-31

Brief Summary

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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

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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

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NAFLD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Placebo

Placebo diet

Group Type PLACEBO_COMPARATOR

Placebo diet

Intervention Type BEHAVIORAL

Placebo diet: normal dietary advice

5:2

5:2 diet

Group Type EXPERIMENTAL

5:2 diet

Intervention Type BEHAVIORAL

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

LCHF

LCHF diet

Group Type EXPERIMENTAL

LCHF

Intervention Type BEHAVIORAL

Dietary intervention according to LCHF diet during three months.

Interventions

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5:2 diet

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

Intervention Type BEHAVIORAL

LCHF

Dietary intervention according to LCHF diet during three months.

Intervention Type BEHAVIORAL

Placebo diet

Placebo diet: normal dietary advice

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Known NAFLD

Exclusion Criteria

* Other forms of liver disease
* Bolus insulin treatment
* Cirrhosis
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hannes Hagström

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hannes Hagström, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Center for Digestive Diseases, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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 Aug 12:1-9. doi: 10.1080/00365521.2025.2544305. Online ahead of print.

Reference Type DERIVED
PMID: 40797298 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33898960 (View on PubMed)

Other Identifiers

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Dnr 2017/258-31

Identifier Type: -

Identifier Source: org_study_id

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