search
Back to results

The University of Michigan Wellness for Liver Health Study

Primary Purpose

Nonalcoholic Fatty Liver Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
diet and lifestyle program
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Fatty Liver Disease focused on measuring nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

diet and lifestyle program

Arm 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.

Outcomes

Primary Outcome Measures

Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction
Measured with pre and post MRIs

Secondary Outcome Measures

Change in Liver Stiffness
Change in liver stiffness as measured using Magnetic resonance (MR) elastography
Body Weight Change
Measured with change in body weight

Full Information

First Posted
August 10, 2021
Last Updated
August 8, 2023
Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT05010070
Brief Title
The University of Michigan Wellness for Liver Health Study
Official Title
The University of Michigan Wellness Education for Liver Health Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
October 3, 2022 (Actual)
Study Completion Date
October 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease
Keywords
nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diet and lifestyle program
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
diet and lifestyle program
Intervention Description
See description of main arm.
Primary Outcome Measure Information:
Title
Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction
Description
Measured with pre and post MRIs
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change in Liver Stiffness
Description
Change in liver stiffness as measured using Magnetic resonance (MR) elastography
Time Frame
4 months
Title
Body Weight Change
Description
Measured with change in body weight
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The University of Michigan Wellness for Liver Health Study

We'll reach out to this number within 24 hrs