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

NCT05130346 | Withdrawn

• 1 other identifier: HM20023471
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-Alcoholic Fatty Liver Disease; Fatty Liver, Nonalcoholic; Obesity

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (10)

• Change in total body weight

  Baseline to 12 months

• Change in bilirubin

  Baseline to 12 months

• Change in alanine transaminase (ALT)

  Baseline to 12 months

• Change in aspartate transaminase (AST)

  Baseline to 12 months

• Change in c-reactive protein (CRP)

  Baseline to 12 months

Study Arms (2)

Mindfulness Based Stress Reduction (MBSR)

EXPERIMENTAL

Behavioral: Mindfulness Based Stress Reduction (MBSR)

Standard of Care (SOC)

NO INTERVENTION

Interventions

Mindfulness Based Stress Reduction (MBSR) BEHAVIORAL

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.

Mindfulness Based Stress Reduction (MBSR)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any known cause of liver disease other than NAFLD as confirmed by patient's history, laboratory data, and/or histological findings.
• Decompensated liver cirrhosis based on laboratory data and clinical manifestations (varices, ascites, or encephalopathy).
• Any previous experimental interventional treatment of NAFLD or NASH within the past 3 months.
• Pre-existing diseases/conditions that could interfere with the results or the completion of this trial based on the investigator's judgment.
• Unstable metabolic syndrome and other serious chronic medical conditions.
• 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.
• Unable to adhere to out-patient clinic management program.
• Do not speak English on a daily-user level.
• Pregnant or planning to become pregnant within the following 6 months.
• Active substance use disorder.
• Inmates.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Arun J Sanyal, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 23, 2021
• Study Start: February 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)