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

Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease: Beyond the Paradigm of Weight Loss.

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).

Study Overview

• Status: Withdrawn
• Conditions: Obesity; Non-Alcoholic Fatty Liver Disease; Fatty Liver, Nonalcoholic
• Intervention / Treatment: Behavioral: Mindfulness Based Stress Reduction (MBSR)

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard of Care (SOC)
EXPERIMENTAL: Mindfulness Based Stress Reduction (MBSR)	Behavioral: Mindfulness Based Stress Reduction (MBSR); Participants will be asked to attend group meetings for mindfulness training. Each meeting will last approximately one hour and will take place online via Zoom. The meetings will occur on a weekly basis, over an 8-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total body weight	Relative change (%) in total body weight at 6 months (T1) from baseline (T0).	Baseline to 6 months
Change in bilirubin	Relative change (%) in bilirubin at 6 months (T1) from baseline (T0).	Baseline to 6 months
Change in alanine transaminase (ALT)	Relative change (%) in ALT at 6 months (T1) from baseline (T0).	Baseline to 6 months
Change in aspartate transaminase (AST)	Relative change (%) in AST at 6 months (T1) from baseline (T0).	Baseline to 6 months
Change in alkaline phosphatase (ALP)	Relative change (%) in ALP at 6 months (T1) from baseline (T0).	Baseline to 6 months
Change in c-reactive protein (CRP)	Relative change (%) in CRP at 6 months (T1) from baseline (T0).	Baseline to 6 months
Change in Fibrosis-4 Index (FIB-4)	Relative change (%) in FIB-4 at 6 months (T1) from baseline (T0).	Baseline to 6 months
Change in Enhanced Liver Fibrosis test (ELF)	Relative change (%) in ELF at 6 months (T1) from baseline (T0).	Baseline to 6 months
Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4)	Relative change (%) in NIS4 at 6 months (T1) from baseline (T0).	Baseline to 6 months
Change in liver stiffness	Relative change (%) in liver stiffness as measured by transient elastography at 6 months (T1) from baseline (T0).	Baseline to 6 months
Change in hepatic fat deposition	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).	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total body weight	Relative change (%) in total body weight at 1 year (T2) from 6 months (T1) and baseline (T0).	Baseline to 12 months
Change in bilirubin	Relative change (%) in bilirubin at 1 year (T2) from 6 months (T1) and baseline (T0).	Baseline to 12 months
Change in alanine transaminase (ALT)	Relative change (%) in ALT at 1 year (T2) from 6 months (T1) and baseline (T0).	Baseline to 12 months
Change in aspartate transaminase (AST)	Relative change (%) in AST at 1 year (T2) from 6 months (T1) and baseline (T0).	Baseline to 12 months
Change in c-reactive protein (CRP)	Relative change (%) in CRP at 1 year (T2) from 6 months (T1) and baseline (T0).	Baseline to 12 months
Change in Fibrosis-4 Index (FIB-4)	Relative change (%) in FIB-4 at 1 year (T2) from 6 months (T1) and baseline (T0).	Baseline to 12 months
Change in Enhanced Liver Fibrosis test (ELF)	Relative change (%) in ELF at 1 year (T2) from 6 months (T1) and baseline (T0).	Baseline to 12 months
Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4)	Relative change (%) in NIS4 at 1 year (T2) from 6 months (T1) and baseline (T0).	Baseline to 12 months
Change in alkaline phosphatase (ALP)	Relative change (%) in ALP at 1 year (T2) from 6 months (T1) and baseline (T0).	Baseline to 12 months
Change in hepatic fat deposition	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).	Baseline to 12 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (ACTUAL): November 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: HM20023471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No