Non-Alcoholic Fatty Liver DiseaseNCT05130346
Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease
A study testing Mindfulness Based Stress Reduction (MBSR) in people with Non-Alcoholic Fatty Liver Disease and Fatty Liver, Nonalcoholic, run by Virginia Commonwealth University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic, Obesity
- What is being tested?
- Mindfulness Based Stress Reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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):
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: 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).
Read the 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.
- Being tested
- Mindfulness Based Stress Reduction (MBSR)
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction (MBSR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Experimental | Not described Receives: Behavioral: Mindfulness Based Stress Reduction (MBSR) |
| Standard of Care (SOC) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total body weight
Relative change (%) in total body weight at 6 months (T1) from baseline (T0).
Measured: Baseline to 6 months
Change in bilirubin
Relative change (%) in bilirubin at 6 months (T1) from baseline (T0).
Measured: Baseline to 6 months
Change in alanine transaminase (ALT)
Relative change (%) in ALT at 6 months (T1) from baseline (T0).
Measured: Baseline to 6 months
Change in aspartate transaminase (AST)
Relative change (%) in AST at 6 months (T1) from baseline (T0).
Measured: Baseline to 6 months
Change in alkaline phosphatase (ALP)
Relative change (%) in ALP at 6 months (T1) from baseline (T0).
Measured: Baseline to 6 months
Change in c-reactive protein (CRP)
Relative change (%) in CRP at 6 months (T1) from baseline (T0).
Measured: Baseline to 6 months
Change in Fibrosis-4 Index (FIB-4)
Relative change (%) in FIB-4 at 6 months (T1) from baseline (T0).
Measured: Baseline to 6 months
Change in Enhanced Liver Fibrosis test (ELF)
Relative change (%) in ELF at 6 months (T1) from baseline (T0).
Measured: Baseline to 6 months
Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4)
Relative change (%) in NIS4 at 6 months (T1) from baseline (T0).
Measured: 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).
Measured: 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).
Measured: Baseline to 6 months
Secondary outcomes (10)
Change in total body weight
Relative change (%) in total body weight at 1 year (T2) from 6 months (T1) and baseline (T0).
Measured: Baseline to 12 months
Change in bilirubin
Relative change (%) in bilirubin at 1 year (T2) from 6 months (T1) and baseline (T0).
Measured: Baseline to 12 months
Change in alanine transaminase (ALT)
Relative change (%) in ALT at 1 year (T2) from 6 months (T1) and baseline (T0).
Measured: Baseline to 12 months
Change in aspartate transaminase (AST)
Relative change (%) in AST at 1 year (T2) from 6 months (T1) and baseline (T0).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline to 12 months
Change in alkaline phosphatase (ALP)
Relative change (%) in ALP at 1 year (T2) from 6 months (T1) and baseline (T0).
Measured: 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).
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study startFeb 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: The study is being withdrawn due to difficulties enrolling participants and the loss of the study coordinator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arun J Sanyal, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130346
- Sponsor's protocol ID
- HM20023471
- Status last verified
- Feb 2023
- First submitted
- 11 Nov 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease: Beyond the Paradigm of Weight Loss.
- ClinicalTrials.gov ID
- NCT05130346
- Acronym / sponsor ID
- HM20023471
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study is being withdrawn due to difficulties enrolling participants and the loss of the study coordinator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Experimental | Behavioral: Mindfulness Based Stress Reduction (MBSR) |
| Standard of Care (SOC) | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mindfulness Based Stress Reduction (MBSR) |
Primary outcome
Change in total body weight
Time frame: Baseline to 6 months
Relative change (%) in total body weight at 6 months (T1) from baseline (T0).
Change in bilirubin
Time frame: Baseline to 6 months
Relative change (%) in bilirubin at 6 months (T1) from baseline (T0).
Change in alanine transaminase (ALT)
Time frame: Baseline to 6 months
Relative change (%) in ALT at 6 months (T1) from baseline (T0).
Change in aspartate transaminase (AST)
Time frame: Baseline to 6 months
Relative change (%) in AST at 6 months (T1) from baseline (T0).
Change in alkaline phosphatase (ALP)
Time frame: Baseline to 6 months
Relative change (%) in ALP at 6 months (T1) from baseline (T0).
Change in c-reactive protein (CRP)
Time frame: Baseline to 6 months
Relative change (%) in CRP at 6 months (T1) from baseline (T0).
Change in Fibrosis-4 Index (FIB-4)
Time frame: Baseline to 6 months
Relative change (%) in FIB-4 at 6 months (T1) from baseline (T0).
Change in Enhanced Liver Fibrosis test (ELF)
Time frame: Baseline to 6 months
Relative change (%) in ELF at 6 months (T1) from baseline (T0).
Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4)
Time frame: Baseline to 6 months
Relative change (%) in NIS4 at 6 months (T1) from baseline (T0).
Change in liver stiffness
Time frame: Baseline to 6 months
Relative change (%) in liver stiffness as measured by transient elastography at 6 months (T1) from baseline (T0).
Change in hepatic fat deposition
Time frame: 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).
10 secondary outcomes
Change in total body weight
Time frame: Baseline to 12 months
Change in bilirubin
Time frame: Baseline to 12 months
Change in alanine transaminase (ALT)
Time frame: Baseline to 12 months
Change in aspartate transaminase (AST)
Time frame: Baseline to 12 months
Change in c-reactive protein (CRP)
Time frame: Baseline to 12 months
Change in Fibrosis-4 Index (FIB-4)
Time frame: Baseline to 12 months
Change in Enhanced Liver Fibrosis test (ELF)
Time frame: Baseline to 12 months
Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4)
Time frame: Baseline to 12 months
Change in alkaline phosphatase (ALP)
Time frame: Baseline to 12 months
Change in hepatic fat deposition
Time frame: Baseline to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun J Sanyal, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction (MBSR) in people with Non-Alcoholic Fatty Liver Disease and Fatty Liver, Nonalcoholic, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total body weight (time frame: Baseline to 6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.