Phase 2
Completed N=11
The University of Michigan Wellness for Liver Health Study
Source: ClinicalTrials.gov NCT05010070 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction — -7.06 percentage of liver lobe fat
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction |
-7.06 | — |
| SECONDARY Change in Liver Stiffness |
-0.33 | — |
| SECONDARY Body Weight Change |
-10.69 | — |
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
Data sourced from ClinicalTrials.gov (NCT05010070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.