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Exercise Study in Subjects With NAFLD (BestTreat)

Primary Purpose

Non-Alcoholic Fatty Liver Disease, Gastrointestinal Microbiome, Exercise

Status

Completed

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

high-intensity aerobic interval training

About this trial

This is an interventional basic science trial for Non-Alcoholic Fatty Liver Disease focused on measuring NAFLD, Gut microbiota, high-intensity training

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of Eastern Finland

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control-group

Exercise-group

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in liver fat content

Changes in liver fat content by means of magnetic resonance imaging (MRI) /magnetic resonance spectroscopy (MRS)

Gut microbiota changes

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

Secondary Outcome Measures

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

Changes in protein expression in adipose tissue

To define differences in lipid and glucose metabolism related enzymes, transporters

Changes in low-grade inflammation

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

Body composition will be measured by bioimpedance

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)

Full Information

NCT ID

NCT03995056

First Posted

June 10, 2019

Last Updated

August 8, 2022

Sponsor

University of Eastern Finland

Collaborators

European Commission, Leibniz Institute for Natural Product Research and Infection Biology, Afekta, Novogene, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Clinical Microbiomics, Kuopio Research Institute of Exercise Medicine, Kuopio University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03995056

Brief Title

Exercise Study in Subjects With NAFLD

Acronym

BestTreat

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

April 19, 2019 (Actual)

Primary Completion Date

June 18, 2020 (Actual)

Study Completion Date

June 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Eastern Finland

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Alcoholic Fatty Liver Disease, Gastrointestinal Microbiome, Exercise

Keywords

NAFLD, Gut microbiota, high-intensity training

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control-group

Arm Type

No Intervention

Arm Description

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

Arm Title

Exercise-group

Arm Type

Experimental

Arm Description

This group with diagnosed NAFLD patients will perform a high-intensity aerobic interval exercise training without changing their diets.

Intervention Type

Behavioral

Intervention Name(s)

high-intensity aerobic interval training

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in liver fat content

Description

Changes in liver fat content by means of magnetic resonance imaging (MRI) /magnetic resonance spectroscopy (MRS)

Time Frame

12 weeks (baseline and endpoint)

Title

Gut microbiota changes

Description

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

Time Frame

12 weeks (baseline and endpoint)

Secondary Outcome Measure Information:

Title

Changes in glucose profile

Description

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

Time Frame

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

Title

Changes in protein expression in adipose tissue

Description

To define differences in lipid and glucose metabolism related enzymes, transporters

Time Frame

12 weeks (baseline and endpoint)

Title

Changes in low-grade inflammation

Description

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

Time Frame

12 weeks (baseline and endpoint)

Title

The effect on body composition

Description

Body composition will be measured by bioimpedance

Time Frame

12 weeks (baseline and endpoint)

Title

Changes in metabolomics

Description

Metabolomics (small molecule intermediates and products of metabolism) in stool, blood and urine will be measured by Liquid chromatography-mass spectrometry (LC-MS)

Time Frame

12 weeks (baseline and endpoint)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ursula Schwab, Prof

Organizational Affiliation

University of Eastern Finland

Official's Role

Study Director

Facility Information:

Facility Name

University of Eastern Finland

City

Kuopio

ZIP/Postal Code

70200§§

Country

Finland

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35444259

Citation

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.

Results Reference

background

Links:

URL

https://www.besttreat.eu/

Description

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

Learn more about this trial

Exercise Study in Subjects With NAFLD

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