diet and lifestyle program for Liver Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Liver Diseases+3 More
diet and lifestyle program - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Liver Diseases
  • Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 4 months

4 months
Change in MRI-based liver fibrosis
Change in liver fat content using liver MRI-derived proton density fat fraction
Percent body weight change

Trial Safety

Safety Progress

1 of 3

Side Effects for

Complete Diet and Lifestyle Program
7%kidney stones
3%muscle cramping
3%blurry vision
This histogram enumerates side effects from a completed 2020 Phase 1 & 2 trial (NCT03987854) in the Complete Diet and Lifestyle Program ARM group. Side effects include: kidney stones with 7%, muscle cramping with 3%, blurry vision with 3%.

Trial Design

1 Treatment Group

diet and lifestyle program
1 of 1
Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: diet and lifestyle program · No Placebo Group · Phase 1 & 2

diet and lifestyle program
Behavioral
Experimental Group · 1 Intervention: diet and lifestyle program · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
diet and lifestyle program
2017
Completed Phase 2
~160

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 months

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,418 Previous Clinical Trials
24,557,527 Total Patients Enrolled
7 Trials studying Liver Diseases
316 Patients Enrolled for Liver Diseases
University of MichiganLead Sponsor
1,616 Previous Clinical Trials
6,330,829 Total Patients Enrolled
12 Trials studying Liver Diseases
599 Patients Enrolled for Liver Diseases

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have regular access to the internet.\n
You have been approved by a physician to participate in this study.
You are able to attend in-person appointments in Ann Arbor.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: October 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.