Exercise Study in Subjects With NAFLD

NCT03995056 | Completed

• 1 other identifier: BestTreat
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Non-Alcoholic Fatty Liver Disease; Gastrointestinal Microbiome; Exercise

Keywords

NAFLD; Gut microbiota; high-intensity training

Outcome Measures

Primary Outcomes (2)

• 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)

• Gut microbiota changes

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

  12 weeks (baseline and endpoint)

Secondary Outcomes (5)

• Changes in glucose profile

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

• Changes in protein expression in adipose tissue

  12 weeks (baseline and endpoint)

• Changes in low-grade inflammation

  12 weeks (baseline and endpoint)

• The effect on body composition

  12 weeks (baseline and endpoint)

• Changes in metabolomics

  12 weeks (baseline and endpoint)

Study Arms (2)

Control-group

NO INTERVENTION

Subjects diagnosed with NAFLD and a sedentary lifestyle will have no changes in their habits and diets.

Exercise-group

EXPERIMENTAL

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

Interventions

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.

Exercise-group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

University of Eastern Finland

Kuopio, 70200§§, Finland

Location

Related Publications (2)

• Babu AF, Csader S, Mannisto V, Tauriainen MM, Pentikainen H, Savonen K, Klavus 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.

  PMID: 35444259 BACKGROUND

• Csader S, Chen X, Leung H, Mannisto V, Pentikainen H, Tauriainen M-M, Savonen K, El-Nezami H, Schwab U, Panagiotou G. Gut ecological networks reveal associations between bacteria, exercise, and clinical profile in non-alcoholic fatty liver disease patients. mSystems. 2023 Oct 26;8(5):e0022423. doi: 10.1128/msystems.00224-23. Epub 2023 Aug 22.

  PMID: 37606372 DERIVED

Related Links

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

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Motor Activity

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Behavior

Study Officials

• Ursula Schwab, Prof

  University of Eastern Finland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 21, 2019
• Study Start: April 19, 2019
• Primary Completion: June 18, 2020
• Study Completion: June 18, 2020
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)