The University of Michigan Wellness for Liver Health Study

Nonalcoholic Fatty Liver Disease Clinical Trial

Official title:

The University of Michigan Wellness Education for Liver Health Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05010070
• Other study ID #: HUM00154361
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 31, 2021
• Est. completion date: October 3, 2022

Study information

• Verified date: August 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 3, 2022
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Intervention

Behavioral:
• diet and lifestyle program
See description of main arm.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction	Measured with pre and post MRIs	4 months
Secondary	Change in Liver Stiffness	Change in liver stiffness as measured using Magnetic resonance (MR) elastography	4 months
Secondary	Body Weight Change	Measured with change in body weight	4 months