The University of Michigan Wellness for Liver Health Study

Study Overview
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Brief Summary
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The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for adults with Non-alcoholic Fatty Liver Disease (NAFLD).

Detailed Description
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As there are no medications that effectively treat nonalcoholic fatty liver disease (NAFLD), effective diet and lifestyle treatments are imperative to curb this disease's impact. Our data suggests that insulin resistance is the strongest modifiable risk factor for having NAFLD. Additionally, genetic factors can interact with insulin resistance to multiplicatively increase risk of NAFLD. The investigators hypothesize that a very low-carbohydrate diet and behavioral support program may be able to achieve NAFLD reversal in adults with steatosis and/or mild fibrosis, especially in a subpopulation of rs738409-GG individuals. To prepare to test this, the investigators will conduct a pilot feasibility and acceptability trial of a 4-month online very low-carbohydrate, ketogenic (or keto) program in adults with NAFLD.

Official Title
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The University of Michigan Wellness Education for Liver Health Study

Conditions
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Nonalcoholic Fatty Liver Disease

Intervention / Treatment
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* Behavioral: diet and lifestyle program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have regular access to the internet MRI with liver steatosis but nor cirrhosis Able to consent and follow directions No physical limitations Physician approval to participate Able to attend in-person appointments in Ann Arbor Be identified based on information from the Michigan Genomics Initiative (MGI) database have elevated liver function tests Exclusion Criteria: non-English speaking inability to complete baseline measurements a substance abuse, mental health, or medical condition that would interfere with participation (such as current chemotherapy, heart failure, kidney failure, Cushing's syndrome, etc.) pregnant or planning to get pregnant in the next 6 months type 1 diabetes non-NAFLD causes of elevated liver function tests planned or history of weight loss surgery vegan or vegetarian currently enrolled in a weight loss program or other investigative study that might conflict with this research taking medications known to cause weight gain or loss recent decompensation/hospitalization metal implants/inability to receive MRI

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diet and lifestyle program<br>Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. They will also be taught about positive affect skills (such as gratitude, positive reappraisal, and personal strengths) and mindful eating. | Behavioral: diet and lifestyle program<br>* See description of main arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction | Measured with pre and post MRIs | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Liver Stiffness | Change in liver stiffness as measured using Magnetic resonance (MR) elastography | 4 months | 
| Body Weight Change | Measured with change in body weight | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition