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diet and lifestyle program for Non-alcoholic Fatty Liver Disease

Phase 1 & 2
Waitlist Available
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

Study Summary

This trial will test a very-low carbohydrate diet intervention for adults with Non-alcoholic Fatty Liver Disease.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction
Secondary outcome measures
Body Weight Change
Change in Liver Stiffness

Side effects data

From 2022 Phase 1 & 2 trial • 11 Patients • NCT05010070
9%
diarrhea
9%
flare up of dermatitis
9%
broken foot
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diet and Lifestyle Program

Trial Design

1Treatment groups
Experimental Treatment
Group I: diet and lifestyle programExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
diet and lifestyle program
2017
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,788 Previous Clinical Trials
6,369,582 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
198 Patients Enrolled for Non-alcoholic Fatty Liver Disease
National Institutes of Health (NIH)NIH
2,690 Previous Clinical Trials
6,950,997 Total Patients Enrolled
8 Trials studying Non-alcoholic Fatty Liver Disease
789 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The University of Michigan Wellness for Liver Health Study
Laura Saslow 2021. "The University of Michigan Wellness for Liver Health Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05010070.
~3 spots leftby Apr 2025
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