The University of Michigan Wellness for Liver Health Study

University of Michigan11 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nonalcoholic Fatty Liver Disease

Interventions

diet and lifestyle programBEHAVIORAL

See description of main arm.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction

Measured with pre and post MRIs

Time frame: 4 months

Secondary Outcomes

Change in Liver Stiffness

Change in liver stiffness as measured using Magnetic resonance (MR) elastography

Time frame: 4 months

Body Weight Change

Measured with change in body weight

Time frame: 4 months

Data from ClinicalTrials.gov

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