The University of Michigan Wellness for Liver Health Study

NCT05010070 | Completed Phase 1 Results

• 1 other identifier: HUM00154361
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Nonalcoholic Fatty Liver Disease

Keywords

nutrition

Outcome Measures

Primary Outcomes (1)

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

  Measured with pre and post MRIs

  4 months

Secondary Outcomes (2)

• Change in Liver Stiffness

  4 months

• Body Weight Change

  4 months

Study Arms (1)

diet and lifestyle program

EXPERIMENTAL

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.

Behavioral: diet and lifestyle program

Interventions

diet and lifestyle program BEHAVIORAL

See description of main arm.

diet and lifestyle program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Diet

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Laura Saslow, Associate Professor
• Organization: University of Michigan

saslowl@umich.edu

(734) 764-7836

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 18, 2021
• Study Start: August 31, 2021
• Primary Completion: October 3, 2022
• Study Completion: October 3, 2022
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)