Skip to main content
OpenTrials
Completed

NCT Number: NCT03995056

Exercise Study in Subjects With NAFLD

Non-Alcoholic Fatty Liver Disease is the most common cause of chronic liver diseases. The benign non-alcoholic fatty liver, characterized by excessive fat accumulation, can evolve into non-alcoholic steatohepatitis and liver cancer.

The recommendation nowadays is a lifestyle change with physical exercise and diet to reduce liver fat and improve inflammation. Besides this, a leaky gut and dysbiosis have an impact on the liver, and exercise ameliorates the diversity of gut microbiota and permeability of the intestine.

The aim of this study is to find out a link between exercise and the gut-liver axis regarding the stage of liver adiposity and define exercise-responsive gut microbiome in NAFLD patients

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-Alcoholic Fatty Liver Disease Behavior Digestive System Diseases Exercise Fatty Liver Gastrointestinal Microbiome Liver Diseases Motor Activity

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Eastern Finland

Kuopio, 70200§§, Finland

About this study

For this 12-week randomised controlled intervention 60 subjects between 18 and 70 years old, diagnosed with NAFLD and body mass index under 35 kg/m2 will be recruited. They will be randomly assigned in a high-intensity aerobic interval training (n=30) and a control group with a sedentary lifestyle (n=30). The intervention group follows a supervised high-intensity aerobic interval training two times per week and additionally, an individualised home workout program to have 3 hours of aerobic training per week. Blood samples, adipose tissue biopsy, 24h-urine and faecal samples will be collected at the baseline, midway (only stool) and at the end of the study. Dietary intake will be analysed at weeks 0, 6, 12.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosed NAFLD
  • BMI:25 - 35 kg/m^2

Exclusion criteria

  • acute illness or current evidence of acute or chronic inflammatory or infective diseases
  • liver disease (e.g. Wilsons disease/alpha-1-antitrypsin deficiency, Hepatitis B and C, hemochromatosis)
  • bleeding disorder, anticoagulation medication
  • subjects with diagnosed type 1 diabetes or diagnosed type 2 diabetes with insulin or Glucagon-like peptide-1 agonist treatment
  • diagnosed depression and mental illness
  • any condition preventing physical activity
  • smokers
  • alcohol abuse (daily consumption ≥ 30 g for men and ≥ 20 g for women)

Treatment and study plan

high-intensity aerobic interval training

Behavioral

The intervention group will follow a high-intensity interval training protocol on a cycle ergometer for 2 times per week and 1 time an individualised home workout program to have a total exercise amount of 3 hours.

Leisure time physical activity at baseline as well as during the intervention period will be assessed by Polar Active devices.

Primary outcomes

  1. Changes in liver fat content

    Time frame: 12 weeks (baseline and endpoint)

    Changes in liver fat content by means of magnetic resonance imaging (MRI) /magnetic resonance spectroscopy (MRS)

  2. Gut microbiota changes

    Time frame: 12 weeks (baseline and endpoint)

    Changes in the composition and richness of gut microbiota through metagenomic analyses

Secondary outcomes

  1. Changes in glucose profile

    Time frame: 14 weeks (two weeks preceding the intervention and during the last weeks of the intervention)

    Using Freestyle Libre for 2 weeks before the beginning of the intervention and during the last 2 weeks of the intervention to measure tissue glucose concentrations throughout the day

  2. Changes in protein expression in adipose tissue

    Time frame: 12 weeks (baseline and endpoint)

    To define differences in lipid and glucose metabolism related enzymes, transporters

  3. Changes in low-grade inflammation

    Time frame: 12 weeks (baseline and endpoint)

    Cytokine levels (IL1-RA, TNFα, IL-6, MCP-1, IL-1β, TGF-β, IFN-γ, IL-10) in the blood will be measured by ELISA

  4. The effect on body composition

    Time frame: 12 weeks (baseline and endpoint)

    Body composition will be measured by bioimpedance

  5. Changes in metabolomics

    Time frame: 12 weeks (baseline and endpoint)

    Metabolomics (small molecule intermediates and products of metabolism) in stool, blood and urine will be measured by Liquid chromatography-mass spectrometry (LC-MS)

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Afekta
  • Clinical Microbiomics
  • European Commission
  • Kuopio Research Institute of Exercise Medicine
  • Kuopio University Hospital
  • Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institute
  • Novogene

Registry information

Official study title

A Randomised Controlled Exercise Intervention in Subjects With Non-alcoholic Fatty Liver Disease

Acronym: BestTreat

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2019
Registry last updated
Aug 11, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.