Lifestyle Modification in the Treatment of NAFLD.

NAFLD Clinical Trial

Official title:

Complex Lifestyle Modification in the Treatment of Non-alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816915
• Other study ID #: NU23-01-00288
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: December 2026

Study information

• Verified date: September 2023
• Source: General University Hospital, Prague
• Contact: Radan Bruha, Prof.
• Phone: +420224962506
• Email: bruha[@]cesnet.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The project will study the impact of individually tailored lifestyle counselling compared to standard care on the parameters of NAFLD/NASH in patients with metabolic syndrome. The factors affecting the outcome (including clinical and laboratory parameters and microbiome profiling) will be evaluated.

Description:

Non-alcoholic fatty liver disease (NAFLD), the hepatic manifestation of a metabolic syndrome, is a leading cause of chronic liver disease worldwide. NAFLD is associated with type 2 diabetes, obesity and genetic factors. Despite intensive effort and numerous trials, as of today there is no approved treatment for NAFLD. Weight reduction is recommended, but no long-term control study assessing the evolution of NAFLD/NASH (non-alcoholic steatohepatitis) during lifestyle modification is available.

The main objective of presented project is to compare the progression of NAFLD/NASH in patients with metabolic syndrome randomly assigned to a standard care or a professional lifestyle modification counselling during a 1-yr follow-up. The investigators hypothesize that professionally tailored life-style counselling in patient with metabolic syndrome and NAFLD will improve liver fat content and other non-invasive parameters of liver disease, and factors (including gut microbiota) affecting progression/regression of NAFLD will be identified.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals with NAFLD and metabolic syndrome

Exclusion Criteria:

• Etiology of liver disease other than NAFLD.

• Presence of malignant disease.

• Uncontrolled cardiovascular disease

• Pregnancy.

Related Conditions & MeSH terms

• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Behavioral:
• Cognitive behavioral therapy
Subjects will receive professional lifestyle intervention conducted by STOB organization. Using CBT and the so-called third wave of CBT, especially mindfulness, the patients will be guided by certified experts to increase motivation and to change eating and exercise habits, which will be mapped before and after the intervention.

Locations

Country	Name	City	State
Czechia	General University Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
General University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

Fernandez T, Vinuela M, Vidal C, Barrera F. Lifestyle changes in patients with non-alcoholic fatty liver disease: A systematic review and meta-analysis. PLoS One. 2022 Feb 17;17(2):e0263931. doi: 10.1371/journal.pone.0263931. eCollection 2022. — View Citation

Smid V, Dvorak K, Sedivy P, Kosek V, Lenicek M, Dezortova M, Hajslova J, Hajek M, Vitek L, Bechynska K, Bruha R. Effect of Omega-3 Polyunsaturated Fatty Acids on Lipid Metabolism in Patients With Metabolic Syndrome and NAFLD. Hepatol Commun. 2022 Jun;6(6):1336-1349. doi: 10.1002/hep4.1906. Epub 2022 Feb 11. — View Citation

Zelber-Sagi S, Ratziu V, Oren R. Nutrition and physical activity in NAFLD: an overview of the epidemiological evidence. World J Gastroenterol. 2011 Aug 7;17(29):3377-89. doi: 10.3748/wjg.v17.i29.3377. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of CBT on liver fat content	The effect of CBT on liver fat content measured by MRS (percentual change from baseline).	12 months
Primary	The effect of CBT on inflammatory parameters	The effect of CBT on inflammatory biochemical parameters (percentual change from baseline).	12 months
Primary	The effect of CBT on liver fibrosis	The effect of CBT on liver fibrosis measured by elastography (percentual change from baseline).	12 months