Phase 2 N=11 Treatment

The University of Michigan Wellness for Liver Health Study

Nonalcoholic Fatty Liver Disease

Bottom Line

View on ClinicalTrials.gov: NCT05010070 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction — -7.06 percentage of liver lobe fat

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: diet and lifestyle program (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Oct 2022

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	—

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).

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

View full record on ClinicalTrials.gov →

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.