Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease

Not Applicable

Withdrawn

• Conditions: Non-Alcoholic Fatty Liver Disease; Fatty Liver, Nonalcoholic; Obesity
• Interventions: Behavioral: Mindfulness Based Stress Reduction (MBSR)

• Registration Number: NCT05130346
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

The purpose of this research study is to find out about the usefulness of mindfulness for weight loss and improvement of physical and mental health in people who have non-alcoholic fatty liver disease (NAFLD).

Detailed Description

Adding mindfulness to lifestyle changes for weight loss may improve fatty liver disease in particular and overall health and well-being in general by helping sustain weight loss and maintain a healthy lifestyle. This study will allow researchers to learn more about it.

Non-alcoholic fatty liver disease is a condition where there is accumulation of excess fat in the liver of people who drink little or no alcohol. It is part of the metabolic syndrome characterized by diabetes, or pre-diabetes (insulin resistance), being overweight or obese, elevated blood lipids, as well as high blood pressure, all are risk factors for the disease.

In this study, participants will receive usual care, and in addition, they may be asked to participate in a mindfulness-based stress reduction program for 8 weeks. Usual care involves the routine clinic follow up visits and routine lab tests and imaging studies.

Study Timeline

• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-23
• Status Verified: 2023-02
• Study Start: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Confirmed diagnosis of NAFLD and ALT >35 U/dl.
2. At least 2 features of Metabolic syndrome (defined by Adult Treatment Panel III (2005 revision)).
3. Age 18-80 years.
4. BMI ≥25 Kg/m2.
5. Capable of providing written or signed informed consent.

Exclusion Criteria

1. Any known cause of liver disease other than NAFLD as confirmed by patient's history, laboratory data, and/or histological findings.

2. Decompensated liver cirrhosis based on laboratory data and clinical manifestations (varices, ascites, or encephalopathy).

3. Any previous experimental interventional treatment of NAFLD or NASH within the past 3 months.

4. Pre-existing diseases/conditions that could interfere with the results or the completion of this trial based on the investigator's judgment.

5. Unstable metabolic syndrome and other serious chronic medical conditions.

6. Unstable type 2 diabetes (any of the following):

   • Requiring medication adjustment within the last 3 months.
   • Patients requiring GLP-1 agonists treatment.
   • No more than 10% modification in insulin dose if on insulin.
   • If on SGLT-2 inhibitors, need to be on stable dose with more than 5% weight loss in the last 3 months.

7. Unable to adhere to out-patient clinic management program.

8. Do not speak English on a daily-user level.

9. Pregnant or planning to become pregnant within the following 6 months.

10. Active substance use disorder.

11. Does not accept follow-ups over 1 year from time of inclusion (T0).

12. Inmates.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Based Stress Reduction (MBSR)	Mindfulness Based Stress Reduction (MBSR)	-

Primary Outcome Measures

Name	Time	Method
Change in c-reactive protein (CRP)	Baseline to 6 months	Relative change (%) in CRP at 6 months (T1) from baseline (T0).
Change in bilirubin	Baseline to 6 months	Relative change (%) in bilirubin at 6 months (T1) from baseline (T0).
Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4)	Baseline to 6 months	Relative change (%) in NIS4 at 6 months (T1) from baseline (T0).
Change in hepatic fat deposition	Baseline to 6 months	Relative change (%) in hepatic fat deposition as measured by magnetic resonance imaging (MRI) with proton density fat fraction (PDFF) at 6 months (T1) from baseline (T0).
Change in total body weight	Baseline to 6 months	Relative change (%) in total body weight at 6 months (T1) from baseline (T0).
Change in alanine transaminase (ALT)	Baseline to 6 months	Relative change (%) in ALT at 6 months (T1) from baseline (T0).
Change in aspartate transaminase (AST)	Baseline to 6 months	Relative change (%) in AST at 6 months (T1) from baseline (T0).
Change in alkaline phosphatase (ALP)	Baseline to 6 months	Relative change (%) in ALP at 6 months (T1) from baseline (T0).
Change in Fibrosis-4 Index (FIB-4)	Baseline to 6 months	Relative change (%) in FIB-4 at 6 months (T1) from baseline (T0).
Change in Enhanced Liver Fibrosis test (ELF)	Baseline to 6 months	Relative change (%) in ELF at 6 months (T1) from baseline (T0).
Change in liver stiffness	Baseline to 6 months	Relative change (%) in liver stiffness as measured by transient elastography at 6 months (T1) from baseline (T0).

Secondary Outcome Measures

Name	Time	Method
Change in aspartate transaminase (AST)	Baseline to 12 months	Relative change (%) in AST at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in Enhanced Liver Fibrosis test (ELF)	Baseline to 12 months	Relative change (%) in ELF at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in bilirubin	Baseline to 12 months	Relative change (%) in bilirubin at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in alanine transaminase (ALT)	Baseline to 12 months	Relative change (%) in ALT at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in alkaline phosphatase (ALP)	Baseline to 12 months	Relative change (%) in ALP at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in total body weight	Baseline to 12 months	Relative change (%) in total body weight at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in Fibrosis-4 Index (FIB-4)	Baseline to 12 months	Relative change (%) in FIB-4 at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in c-reactive protein (CRP)	Baseline to 12 months	Relative change (%) in CRP at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4)	Baseline to 12 months	Relative change (%) in NIS4 at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in hepatic fat deposition	Baseline to 12 months	Relative change (%) in hepatic fat deposition as measured by magnetic resonance imaging (MRI) with proton density fat fraction (PDFF) at 1 year (T2) from 6 months (T1) and baseline (T0).

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States