Exercise Study in Subjects With NAFLD (BestTreat)

University of Eastern Finland

Status: Completed

Conditions: Gastrointestinal Microbiome; Exercise; Non-Alcoholic Fatty Liver Disease

Treatments: Behavioral: high-intensity aerobic interval training

Study type: Interventional

Funder types: Other

Identifiers

NCT03995056

BestTreat

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Control-group

No Intervention group

Description:

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

Exercise-group

Experimental group

Description:

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

Treatment:

Behavioral: high-intensity aerobic interval training