NCT03995056

Exercise Study in Subjects With NAFLD

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University of Eastern Finland · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Gastrointestinal Microbiome
• Exercise

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-19
• Primary completion: 2020-06-18
• Completion: 2020-06-18
• First posted: 2019-06-21
• Last updated: 2022-08-11

Locations

1 site across 1 country: Finland