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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05130346
Collaborator
(none)
20
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2
15
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Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness Based Stress Reduction (MBSR)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease: Beyond the Paradigm of Weight Loss.
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

No Intervention: Standard of Care (SOC)

Outcome Measures

Primary Outcome Measures

  1. Change in total body weight [Baseline to 6 months]

    Relative change (%) in total body weight at 6 months (T1) from baseline (T0).

  2. Change in bilirubin [Baseline to 6 months]

    Relative change (%) in bilirubin at 6 months (T1) from baseline (T0).

  3. Change in alanine transaminase (ALT) [Baseline to 6 months]

    Relative change (%) in ALT at 6 months (T1) from baseline (T0).

  4. Change in aspartate transaminase (AST) [Baseline to 6 months]

    Relative change (%) in AST at 6 months (T1) from baseline (T0).

  5. Change in alkaline phosphatase (ALP) [Baseline to 6 months]

    Relative change (%) in ALP at 6 months (T1) from baseline (T0).

  6. Change in c-reactive protein (CRP) [Baseline to 6 months]

    Relative change (%) in CRP at 6 months (T1) from baseline (T0).

  7. Change in Fibrosis-4 Index (FIB-4) [Baseline to 6 months]

    Relative change (%) in FIB-4 at 6 months (T1) from baseline (T0).

  8. Change in Enhanced Liver Fibrosis test (ELF) [Baseline to 6 months]

    Relative change (%) in ELF at 6 months (T1) from baseline (T0).

  9. Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4) [Baseline to 6 months]

    Relative change (%) in NIS4 at 6 months (T1) from baseline (T0).

  10. 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).

  11. 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).

Secondary Outcome Measures

  1. 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).

  2. Change in bilirubin [Baseline to 12 months]

    Relative change (%) in bilirubin at 1 year (T2) from 6 months (T1) and baseline (T0).

  3. Change in alanine transaminase (ALT) [Baseline to 12 months]

    Relative change (%) in ALT at 1 year (T2) from 6 months (T1) and baseline (T0).

  4. Change in aspartate transaminase (AST) [Baseline to 12 months]

    Relative change (%) in AST at 1 year (T2) from 6 months (T1) and baseline (T0).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. Change in alkaline phosphatase (ALP) [Baseline to 12 months]

    Relative change (%) in ALP at 1 year (T2) from 6 months (T1) and baseline (T0).

  10. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. NAFLD; defined by CAP >300 dB/m, liver stiffness >6.5 kPa and <14 kPa and alanine transaminase (ALT) >30 U/dl.

  2. At least 2 features of Metabolic syndrome (defined by World Health Organization (WHO)).

  3. Stable medical and clinical condition.

  4. Age 18-80 years.

  5. BMI ≥25 Kg/m2.

  6. Capable of providing written 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.

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

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

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

  4. Active substance use disorder.

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

  6. Inmates.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23298

Sponsors and Collaborators

  • Virginia Commonwealth University

Investigators

  • Principal Investigator: Arun J Sanyal, MD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT05130346
Other Study ID Numbers:
  • HM20023471
First Posted:
Nov 23, 2021
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2022