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Non-Alcoholic Fatty Liver DiseaseBestTreatNCT03995056

Exercise Study in Subjects With NAFLD

A study testing high-intensity aerobic interval training in people with Non-Alcoholic Fatty Liver Disease and Gastrointestinal Microbiome, run by University of Eastern Finland at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
high-intensity aerobic interval training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteFinland
Study dates
19 Apr 2019to 18 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • University of Eastern Finland

    Kuopio, 70200§§

Other trials in Finland

About this study

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

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

Read the 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.

Being tested
high-intensity aerobic interval training
Keywords
NAFLD, Gut microbiota, high-intensity training
Medical subject headings
Non-alcoholic Fatty Liver Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high-intensity aerobic interval trainingBehavioural

    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.

Study groups in NCT03995056
Study groupRoleWhat they receive
Control-groupNo interventionSubjects diagnosed with NAFLD and a sedentary lifestyle will have no changes in their habits and diets.
Exercise-groupExperimentalThis group with diagnosed NAFLD patients will perform a high-intensity aerobic interval exercise training without changing their diets.
Receives: Behavioral: high-intensity aerobic interval training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in liver fat content

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

    Measured: 12 weeks (baseline and endpoint)

  2. Gut microbiota changes

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

    Measured: 12 weeks (baseline and endpoint)

Secondary outcomes (5)

  1. 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

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

  2. Changes in protein expression in adipose tissue

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

    Measured: 12 weeks (baseline and endpoint)

  3. 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

    Measured: 12 weeks (baseline and endpoint)

  4. The effect on body composition

    Body composition will be measured by bioimpedance

    Measured: 12 weeks (baseline and endpoint)

  5. 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)

    Measured: 12 weeks (baseline and endpoint)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2019
  2. Study start19 Apr 2019
  3. Primary completion18 Jun 2020
  4. Study completion18 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03995056
Sponsor's protocol ID
BestTreat
Acronym
BestTreat
Status last verified
Aug 2022
First submitted
10 Jun 2019
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35444259

  • 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.

    PubMed 37606372

Questions about this trial

What is this clinical trial studying?

A study testing high-intensity aerobic interval training in people with Non-Alcoholic Fatty Liver Disease and Gastrointestinal Microbiome, run by University of Eastern Finland at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in liver fat content (time frame: 12 weeks (baseline and endpoint)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03995056, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.

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