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Completed

NCT Number: NCT05010070

The University of Michigan Wellness 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diet and lifestyle program

Behavioral

See description of main arm.

Primary outcomes

  1. Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction

    Time frame: 4 months

    Measured with pre and post MRIs

Secondary outcomes

  1. Change in Liver Stiffness

    Time frame: 4 months

    Change in liver stiffness as measured using Magnetic resonance (MR) elastography

  2. Body Weight Change

    Time frame: 4 months

    Measured with change in body weight

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

The University of Michigan Wellness Education for Liver Health Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2021
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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