The University of Michigan Wellness for Liver Health Study

University of Michigan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Nonalcoholic Fatty Liver Disease

Treatments: Behavioral: diet and lifestyle program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05010070

HUM00154361

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

diet and lifestyle program

Experimental group

Description:

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.

Treatment:

Behavioral: diet and lifestyle program