Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2019-04-19
2020-06-18
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Control-group
Subjects diagnosed with NAFLD and a sedentary lifestyle will have no changes in their habits and diets.
No interventions assigned to this group
Exercise-group
This group with diagnosed NAFLD patients will perform a high-intensity aerobic interval exercise training without changing their diets.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* BMI:25 - 35 kg/m\^2
Exclusion Criteria
* 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)
18 Years
70 Years
ALL
No
Sponsors
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European Commission
OTHER
Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institute
OTHER
Afekta
UNKNOWN
Novogene
UNKNOWN
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Clinical Microbiomics
UNKNOWN
Kuopio Research Institute of Exercise Medicine
OTHER
Kuopio University Hospital
OTHER
University of Eastern Finland
OTHER
Responsible Party
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Principal Investigators
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Ursula Schwab, Prof
Role: STUDY_DIRECTOR
University of Eastern Finland
Locations
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University of Eastern Finland
Kuopio, , Finland
Countries
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References
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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.
Related Links
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European Union Project: "Building a Gut Microbiome Engineering Toolbox for In-Situ Therapeutic Treatments for Non-alcoholic Fatty Liver Disease"
Other Identifiers
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BestTreat
Identifier Type: -
Identifier Source: org_study_id
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