NCT05010070

The University of Michigan Wellness for Liver Health Study

The University of Michigan Wellness Education for Liver Health Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Nonalcoholic Fatty Liver Disease

Interventions

Type	Name	Description
BEHAVIORAL	diet and lifestyle program	See description of main arm.

Timeline

• Start date: 2021-08-31
• Primary completion: 2022-10-03
• Completion: 2022-10-03
• First posted: 2021-08-18
• Last updated: 2023-08-14
• Results posted: 2023-08-14

Locations

1 site across 1 country: United States