Exercise Study in Subjects With NAFLD

Exercise Clinical Trial

— BestTreat  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995056
• Other study ID #: BestTreat
• Status: Completed
• Phase: N/A
• Start date: April 19, 2019
• Est. completion date: June 18, 2020

Study information

• Verified date: August 2022
• Source: University of Eastern Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 18, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Exercise
• Fatty Liver
• Gastrointestinal Microbiome
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

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.

Locations

Country	Name	City	State
Finland	University of Eastern Finland	Kuopio

Sponsors (9)

Lead Sponsor	Collaborator
University of Eastern Finland	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, Novogene

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Babu AF, Csader S, Männistö V, Tauriainen MM, Pentikäinen H, Savonen K, Klåvus A, Koistinen V, Hanhineva K, Schwab U. Effects of exercise on NAFLD using non-targeted metabolomics in adipose tissue, plasma, urine, and stool. Sci Rep. 2022 Apr 20;12(1):6485. doi: 10.1038/s41598-022-10481-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in liver fat content	Changes in liver fat content by means of magnetic resonance imaging (MRI) /magnetic resonance spectroscopy (MRS)	12 weeks (baseline and endpoint)
Primary	Gut microbiota changes	Changes in the composition and richness of gut microbiota through metagenomic analyses	12 weeks (baseline and endpoint)
Secondary	Changes in glucose profile	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	14 weeks (two weeks preceding the intervention and during the last weeks of the intervention)
Secondary	Changes in protein expression in adipose tissue	To define differences in lipid and glucose metabolism related enzymes, transporters	12 weeks (baseline and endpoint)
Secondary	Changes in low-grade inflammation	Cytokine levels (IL1-RA, TNFa, IL-6, MCP-1, IL-1ß, TGF-ß, IFN-?, IL-10) in the blood will be measured by ELISA	12 weeks (baseline and endpoint)
Secondary	The effect on body composition	Body composition will be measured by bioimpedance	12 weeks (baseline and endpoint)
Secondary	Changes in metabolomics	Metabolomics (small molecule intermediates and products of metabolism) in stool, blood and urine will be measured by Liquid chromatography-mass spectrometry (LC-MS)	12 weeks (baseline and endpoint)

External Links

•   European Union Project: "Building a Gut Microbiome Engineering Toolbox for In-Situ Therapeutic Treatments for Non-alcoholic Fatty Liver Disease"