Exercise Study in Subjects With NAFLD

NCT ID: NCT03995056

Last Updated: 2022-08-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-19

Study Completion Date

2020-06-18

Brief Summary

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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

Detailed Description

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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.

Conditions

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Non-Alcoholic Fatty Liver Disease Gastrointestinal Microbiome Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

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.

Group Type NO_INTERVENTION

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.

Group Type EXPERIMENTAL

high-intensity aerobic interval training

Intervention Type 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.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Commission

OTHER

Sponsor Role collaborator

Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institute

OTHER

Sponsor Role collaborator

Afekta

UNKNOWN

Sponsor Role collaborator

Novogene

UNKNOWN

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role collaborator

Clinical Microbiomics

UNKNOWN

Sponsor Role collaborator

Kuopio Research Institute of Exercise Medicine

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Finland

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.

Reference Type BACKGROUND
PMID: 35444259 (View on PubMed)

Related Links

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https://www.besttreat.eu/

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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