Back to resultsEffects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease
Primary Purpose
Non-Alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic, Obesity
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction (MBSR)
Sponsored by
About this trial
This is an interventional supportive care trial for Non-Alcoholic Fatty Liver Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Does not accept follow-ups over 1 year from time of inclusion (T0).
- Inmates.
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness Based Stress Reduction (MBSR)
Standard of Care (SOC)
Arm Description
Outcomes
Primary Outcome Measures
Change in total body weight
Relative change (%) in total body weight at 6 months (T1) from baseline (T0).
Change in bilirubin
Relative change (%) in bilirubin at 6 months (T1) from baseline (T0).
Change in alanine transaminase (ALT)
Relative change (%) in ALT at 6 months (T1) from baseline (T0).
Change in aspartate transaminase (AST)
Relative change (%) in AST at 6 months (T1) from baseline (T0).
Change in alkaline phosphatase (ALP)
Relative change (%) in ALP at 6 months (T1) from baseline (T0).
Change in c-reactive protein (CRP)
Relative change (%) in CRP at 6 months (T1) from baseline (T0).
Change in Fibrosis-4 Index (FIB-4)
Relative change (%) in FIB-4 at 6 months (T1) from baseline (T0).
Change in Enhanced Liver Fibrosis test (ELF)
Relative change (%) in ELF at 6 months (T1) from baseline (T0).
Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4)
Relative change (%) in NIS4 at 6 months (T1) from baseline (T0).
Change in liver stiffness
Relative change (%) in liver stiffness as measured by transient elastography at 6 months (T1) from baseline (T0).
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).
Secondary Outcome Measures
Change in total body weight
Relative change (%) in total body weight at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in bilirubin
Relative change (%) in bilirubin at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in alanine transaminase (ALT)
Relative change (%) in ALT at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in aspartate transaminase (AST)
Relative change (%) in AST at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in c-reactive protein (CRP)
Relative change (%) in CRP at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in Fibrosis-4 Index (FIB-4)
Relative change (%) in FIB-4 at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in Enhanced Liver Fibrosis test (ELF)
Relative change (%) in ELF at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4)
Relative change (%) in NIS4 at 1 year (T2) from 6 months (T1) and baseline (T0).
Change in alkaline phosphatase (ALP)
Relative change (%) in ALP at 1 year (T2) from 6 months (T1) and baseline (T0).
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).
Full Information
NCT ID
NCT05130346
First Posted
November 11, 2021
Last Updated
February 3, 2023
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT05130346
Brief Title
Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease
Official Title
Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease: Beyond the Paradigm of Weight Loss.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
The study is being withdrawn due to difficulties enrolling participants and the loss of the study coordinator
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic, Obesity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Based Stress Reduction (MBSR)
Arm Type
Experimental
Arm Title
Standard of Care (SOC)
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction (MBSR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in total body weight
Description
Relative change (%) in total body weight at 6 months (T1) from baseline (T0).
Time Frame
Baseline to 6 months
Title
Change in bilirubin
Description
Relative change (%) in bilirubin at 6 months (T1) from baseline (T0).
Time Frame
Baseline to 6 months
Title
Change in alanine transaminase (ALT)
Description
Relative change (%) in ALT at 6 months (T1) from baseline (T0).
Time Frame
Baseline to 6 months
Title
Change in aspartate transaminase (AST)
Description
Relative change (%) in AST at 6 months (T1) from baseline (T0).
Time Frame
Baseline to 6 months
Title
Change in alkaline phosphatase (ALP)
Description
Relative change (%) in ALP at 6 months (T1) from baseline (T0).
Time Frame
Baseline to 6 months
Title
Change in c-reactive protein (CRP)
Description
Relative change (%) in CRP at 6 months (T1) from baseline (T0).
Time Frame
Baseline to 6 months
Title
Change in Fibrosis-4 Index (FIB-4)
Description
Relative change (%) in FIB-4 at 6 months (T1) from baseline (T0).
Time Frame
Baseline to 6 months
Title
Change in Enhanced Liver Fibrosis test (ELF)
Description
Relative change (%) in ELF at 6 months (T1) from baseline (T0).
Time Frame
Baseline to 6 months
Title
Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4)
Description
Relative change (%) in NIS4 at 6 months (T1) from baseline (T0).
Time Frame
Baseline to 6 months
Title
Change in liver stiffness
Description
Relative change (%) in liver stiffness as measured by transient elastography at 6 months (T1) from baseline (T0).
Time Frame
Baseline to 6 months
Title
Change in hepatic fat deposition
Description
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).
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Change in total body weight
Description
Relative change (%) in total body weight at 1 year (T2) from 6 months (T1) and baseline (T0).
Time Frame
Baseline to 12 months
Title
Change in bilirubin
Description
Relative change (%) in bilirubin at 1 year (T2) from 6 months (T1) and baseline (T0).
Time Frame
Baseline to 12 months
Title
Change in alanine transaminase (ALT)
Description
Relative change (%) in ALT at 1 year (T2) from 6 months (T1) and baseline (T0).
Time Frame
Baseline to 12 months
Title
Change in aspartate transaminase (AST)
Description
Relative change (%) in AST at 1 year (T2) from 6 months (T1) and baseline (T0).
Time Frame
Baseline to 12 months
Title
Change in c-reactive protein (CRP)
Description
Relative change (%) in CRP at 1 year (T2) from 6 months (T1) and baseline (T0).
Time Frame
Baseline to 12 months
Title
Change in Fibrosis-4 Index (FIB-4)
Description
Relative change (%) in FIB-4 at 1 year (T2) from 6 months (T1) and baseline (T0).
Time Frame
Baseline to 12 months
Title
Change in Enhanced Liver Fibrosis test (ELF)
Description
Relative change (%) in ELF at 1 year (T2) from 6 months (T1) and baseline (T0).
Time Frame
Baseline to 12 months
Title
Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4)
Description
Relative change (%) in NIS4 at 1 year (T2) from 6 months (T1) and baseline (T0).
Time Frame
Baseline to 12 months
Title
Change in alkaline phosphatase (ALP)
Description
Relative change (%) in ALP at 1 year (T2) from 6 months (T1) and baseline (T0).
Time Frame
Baseline to 12 months
Title
Change in hepatic fat deposition
Description
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).
Time Frame
Baseline to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Does not accept follow-ups over 1 year from time of inclusion (T0).
Inmates.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arun J Sanyal, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease
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