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Exercise Study in Subjects With NAFLD (BestTreat)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995056
Recruitment Status : Completed
First Posted : June 21, 2019
Last Update Posted : June 23, 2020
Sponsor:
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
Information provided by (Responsible Party):
University of Eastern Finland

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


Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Gastrointestinal Microbiome Exercise Behavioral: high-intensity aerobic interval training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Basic Science
Official Title: A Randomised Controlled Exercise Intervention in Subjects With Non-alcoholic Fatty Liver Disease
Actual Study Start Date : April 19, 2019
Actual Primary Completion Date : June 18, 2020
Actual Study Completion Date : June 18, 2020


Arm Intervention/treatment
No Intervention: Control-group
Subjects diagnosed with NAFLD and a sedentary lifestyle will have no changes in their habits and diets.
Experimental: Exercise-group
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

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 Measures :
  1. Changes in liver fat content [ Time Frame: 12 weeks (baseline and endpoint) ]
    Changes in liver fat content by means of magnetic resonance imaging (MRI) /magnetic resonance spectroscopy (MRS)

  2. Gut microbiota changes [ Time Frame: 12 weeks (baseline and endpoint) ]
    Changes in the composition and richness of gut microbiota through metagenomic analyses


Secondary Outcome Measures :
  1. Changes in glucose profile [ Time Frame: 14 weeks (two weeks preceding the intervention and during the last weeks of the intervention) ]
    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

  2. Changes in protein expression in adipose tissue [ Time Frame: 12 weeks (baseline and endpoint) ]
    To define differences in lipid and glucose metabolism related enzymes, transporters

  3. Changes in low-grade inflammation [ Time Frame: 12 weeks (baseline and endpoint) ]
    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

  4. The effect on body composition [ Time Frame: 12 weeks (baseline and endpoint) ]
    Body composition will be measured by bioimpedance

  5. Changes in metabolomics [ Time Frame: 12 weeks (baseline and endpoint) ]
    Metabolomics (small molecule intermediates and products of metabolism) in stool, blood and urine will be measured by Liquid chromatography-mass spectrometry (LC-MS)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995056


Locations
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Finland
University of Eastern Finland
Kuopio, Finland, 70200§§
Sponsors and Collaborators
University of Eastern Finland
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
Investigators
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Study Director: Ursula Schwab, Prof University of Eastern Finland
Additional Information:
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Responsible Party: University of Eastern Finland
ClinicalTrials.gov Identifier: NCT03995056    
Other Study ID Numbers: BestTreat
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Eastern Finland:
NAFLD
Gut microbiota
high-intensity training
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases