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Completed

NCT Number: NCT02558530

Resolution of Liver Fat in Non-alcoholic Fatty Liver Disease

The major adverse health consequences of obesity occur only when non-alcoholic fatty liver disease (NAFLD) also develops. NAFLD is characterized by abnormal hepatic accumulation of triglycerides and other lipids. The first-line approach to NAFLD management is caloric restriction and weight loss, but these remain difficult to achieve. Little attention has been given to dietary carbohydrate restriction, despite recent reports showing that hepatic de novo lipogenesis, a process that converts dietary carbohydrates into fatty acids in the postprandial state, accounts for approximately 25% of liver triglyceride content in hyperinsulinemic subjects with NAFLD. For comparison, only 15% of the liver triglycerides were derived from dietary fatty acids in patients with NAFLD who had consumed a standardized 30% fat diet for four days before being assessed.

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RPU Diabetes and Obesity, Biomedicum, Helsinki, Finland

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About this study

To establish the time-course of hepatic fat loss in NAFLD subjects on a carbohydrate-restricted diet (<20 g/day), a serial assessments of liver fat during two week diet will be performed. Also, markers of lipid and insulin metabolism, liver function test and changes in gut microbiota during rapid metabolic improvement will be assessed.

The overall aim is to exploit this unique set of human material to determine the specific cellular and molecular pathways that are modified in the early stages of metabolic improvement and fatty liver regression.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • increased liver fat above 5 % in magnetic resonance spectroscopy
  • body mass index 27-39.9 kg/m2

Exclusion criteria

  • liver cirrhosis
  • portal hypertension
  • chronic liver disease other than NAFLD
  • diabetes mellitus or other significant endocrine disease
  • any medication acting on nuclear hormone receptors or inducing liver enzymes or self-administration of supplements other than calcium or vitamins/trace elements
  • any significant cardiovascular co-morbidity
  • history of non-compliance
  • genotype (PNPLA3-MM and TM6SF2-TT) promoting liver fat accumulation

Treatment and study plan

Low carbohydrate diet

Other

Isocaloric, carbohydrate restricted diet 14 days

Primary outcomes

  1. Liver fat percent by nuclear magnetic resonance imaging

    Time frame: 14 days

    Liver fat percent measured by nuclear magnetic resonance imaging

Secondary outcomes

  1. De novo lipogenesis measured as Incorporation of new fatty acids (%) to very-low density lipoprotein triglycerides

    Time frame: 14 days

  2. Gut microbiota measured as change in microbiome profile from baseline

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Göteborg University
  • Sahlgrenska University Hospital

Registry information

Official study title

Rapid Resolution of Human Fatty Liver Disease, the Key to Obesity-related Morbidity and Mortality

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Sep 24, 2015
Registry last updated
Apr 12, 2022

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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