Trial Outcomes & Findings for The University of Michigan Wellness for Liver Health Study (NCT NCT05010070)

NCT ID: NCT05010070

Last Updated: 2023-08-14

Results Overview

Measured with pre and post MRIs

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2023-08-14

Participant Flow

Participant milestones

Measure	Diet and Lifestyle Program 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.
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Diet and Lifestyle Program 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.
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

The University of Michigan Wellness for Liver Health Study

Baseline characteristics by cohort

Measure	Diet and Lifestyle Program n=11 Participants 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.
Age, Continuous	58.22 years STANDARD_DEVIATION 11.23 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Population: We analyzed all participants with outcome data.

Measured with pre and post MRIs

Outcome measures

Measure	Diet and Lifestyle Program n=8 Participants 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.
Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction	-7.06 percentage of liver lobe fat Interval -15.5 to 1.37

SECONDARY outcome

Timeframe: 4 months

Population: We analyzed all participants with outcome data.

Change in liver stiffness as measured using Magnetic resonance (MR) elastography

Outcome measures

Measure	Diet and Lifestyle Program n=6 Participants 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.
Change in Liver Stiffness	-0.33 kilopascals (kPa) Interval -0.82 to 0.17

SECONDARY outcome

Timeframe: 4 months

Population: We analyzed all participants with outcome data.

Measured with change in body weight

Outcome measures

Measure	Diet and Lifestyle Program n=9 Participants 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.
Body Weight Change	-10.69 kg Interval -13.37 to -8.0

Adverse Events

Diet and Lifestyle Program

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Diet and Lifestyle Program n=11 participants at risk 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.
Gastrointestinal disorders diarrhea	9.1% 1/11 • Number of events 1 • 4 months
Skin and subcutaneous tissue disorders flare up of dermatitis	9.1% 1/11 • Number of events 1 • 4 months
Musculoskeletal and connective tissue disorders broken foot	9.1% 1/11 • Number of events 1 • 4 months

Additional Information

Laura Saslow, Associate Professor

University of Michigan

Phone: (734) 764-7836

Email: saslowl@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place