Exercise Study in Subjects With NAFLD

Not Applicable

Completed

• Conditions: Exercise; Gastrointestinal Microbiome; Non-Alcoholic Fatty Liver Disease
• Interventions: Behavioral: high-intensity aerobic interval training

• Registration Number: NCT03995056
• Lead Sponsor: 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

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 Timeline

• Study Start: 2019-04-19
• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-20
• Study First Posted: 2019-06-21
• Primary Completion: 2020-06-18
• Study Completion: 2020-06-18
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Gut microbiota changes	12 weeks (baseline and endpoint)	Changes in the composition and richness of gut microbiota through metagenomic analyses
Changes in liver fat content	12 weeks (baseline and endpoint)	Changes in liver fat content by means of magnetic resonance imaging (MRI) /magnetic resonance spectroscopy (MRS)

Secondary Outcome Measures

Name	Time	Method
Changes in glucose profile	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
The effect on body composition	12 weeks (baseline and endpoint)	Body composition will be measured by bioimpedance
Changes in protein expression in adipose tissue	12 weeks (baseline and endpoint)	To define differences in lipid and glucose metabolism related enzymes, transporters
Changes in low-grade inflammation	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
Changes in metabolomics	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)

Trial Locations

Locations (1)

University of Eastern Finland; 🇫🇮 Kuopio, Finland