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Exercise Study in Subjects With NAFLD (BestTreat)

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


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.
Study Design
Layout table for study information
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
Arms and Interventions
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.
Outcome Measures
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)


Eligibility Criteria
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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)
Contacts and Locations

Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Ursula Schwab, Prof University of Eastern Finland
Tracking Information
First Submitted Date  ICMJE June 10, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date June 23, 2020
Actual Study Start Date  ICMJE April 19, 2019
Actual Primary Completion Date June 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • 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)
  • Gut microbiota changes [ Time Frame: 12 weeks (baseline and endpoint) ]
    Changes in the composition and richness of gut microbiota through metagenomic analyses
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • 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
  • 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
  • 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
  • The effect on body composition [ Time Frame: 12 weeks (baseline and endpoint) ]
    Body composition will be measured by bioimpedance
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Study in Subjects With NAFLD
Official Title  ICMJE A Randomised Controlled Exercise Intervention in Subjects With Non-alcoholic Fatty Liver Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Non-Alcoholic Fatty Liver Disease
  • Gastrointestinal Microbiome
  • Exercise
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: high-intensity aerobic interval training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2020) 		49
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2019) 		60
Actual Study Completion Date  ICMJE June 18, 2020
Actual Primary Completion Date June 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03995056
Other Study ID Numbers  ICMJE BestTreat
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Eastern Finland
Study Sponsor  ICMJE University of Eastern Finland
Collaborators  ICMJE
  • 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  ICMJE
Study Director: Ursula Schwab, Prof University of Eastern Finland
PRS Account University of Eastern Finland
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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