Treatment of NAFLD With Two Different Diets (TREND)

Karolinska University Hospital

Status and phase: Completed; Phase 2

Conditions: NAFLD

Treatments: Behavioral: LCHF; Behavioral: 5:2 diet; Behavioral: Placebo diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03118310

Dnr 2017/258-31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Known NAFLD

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo diet

Treatment:

Behavioral: Placebo diet

5:2

Experimental group

Description:

5:2 diet

Treatment:

Behavioral: 5:2 diet

LCHF

Experimental group

Description:

LCHF diet

Treatment:

Behavioral: LCHF