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OpenTrials
Completed

NCT Number: NCT03118310

Treatment of NAFLD With Two Different Diets

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.

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Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Center for Digestive Diseases, Karolinska University Hospital

Stockholm, 14186, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Known NAFLD

Exclusion criteria

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

Treatment and study plan

5:2 diet

Behavioral

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

LCHF

Behavioral

Dietary intervention according to LCHF diet during three months.

Placebo diet

Behavioral

Placebo diet: normal dietary advice

Primary outcomes

  1. Liver fat

    Time frame: Three months

    MRI-measured liver fat content

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Acronym: TREND

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 18, 2017
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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