Treatment of NAFLD With Two Different Diets

Phase 2

Completed

• Conditions: NAFLD
• Interventions: Behavioral: Placebo diet; Behavioral: LCHF

• Registration Number: NCT03118310
• Lead Sponsor: Karolinska University Hospital

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.

Study Timeline

• Study Start: 2017-04-06
• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-18
• Status Verified: 2020-08
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Known NAFLD

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo diet	Placebo diet
LCHF	LCHF	LCHF diet

Primary Outcome Measures

Name	Time	Method
Liver fat	Three months	MRI-measured liver fat content

Trial Locations

Locations (1)

Center for Digestive Diseases, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden