The University of Michigan Wellness for Liver Health Study

The University of Michigan Wellness Education for Liver Health Study

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).

Study Overview

• Status: Completed
• Conditions: Nonalcoholic Fatty Liver Disease
• Intervention / Treatment: Behavioral: diet and lifestyle program

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: diet and lifestyle program; 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; See description of main arm.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): October 3, 2022
• Study Completion (Actual): October 3, 2022

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: nutrition
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: HUM00154361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No