Exercise Study in Subjects With NAFLD (BestTreat)
|ClinicalTrials.gov Identifier: NCT03995056|
Recruitment Status : Completed
First Posted : June 21, 2019
Last Update Posted : June 23, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Non-Alcoholic Fatty Liver Disease Gastrointestinal Microbiome Exercise||Behavioral: high-intensity aerobic interval training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The study contains two arms. One arm is the control group without any changes in their lifestyle (sedentary lifestyle) and the other arm is the intervention group with a high-intensity interval training. Both groups have no changes in their diets.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Randomised Controlled Exercise Intervention in Subjects With Non-alcoholic Fatty Liver Disease|
|Actual Study Start Date :||April 19, 2019|
|Actual Primary Completion Date :||June 18, 2020|
|Actual Study Completion Date :||June 18, 2020|
No Intervention: Control-group
Subjects diagnosed with NAFLD and a sedentary lifestyle will have no changes in their habits and diets.
This group with diagnosed NAFLD patients will perform a high-intensity aerobic interval exercise training without changing their diets.
Behavioral: high-intensity aerobic interval training
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.
- 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)
- Gut microbiota changes [ Time Frame: 12 weeks (baseline and endpoint) ]Changes in the composition and richness of gut microbiota through metagenomic analyses
- 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
- 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
- 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
- The effect on body composition [ Time Frame: 12 weeks (baseline and endpoint) ]Body composition will be measured by bioimpedance
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995056
|University of Eastern Finland|
|Kuopio, Finland, 70200§§|
|Study Director:||Ursula Schwab, Prof||University of Eastern Finland|