Nonalcoholic Fatty Liver Disease
Conditions
Keywords
nutrition
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).
Detailed description
As there are no medications that effectively treat nonalcoholic fatty liver disease (NAFLD), effective diet and lifestyle treatments are imperative to curb this disease's impact. Our data suggests that insulin resistance is the strongest modifiable risk factor for having NAFLD. Additionally, genetic factors can interact with insulin resistance to multiplicatively increase risk of NAFLD. The investigators hypothesize that a very low-carbohydrate diet and behavioral support program may be able to achieve NAFLD reversal in adults with steatosis and/or mild fibrosis, especially in a subpopulation of rs738409-GG individuals. To prepare to test this, the investigators will conduct a pilot feasibility and acceptability trial of a 4-month online very low-carbohydrate, ketogenic (or keto) program in adults with NAFLD.
Interventions
BEHAVIORALdiet and lifestyle program
See description of main arm.
Sponsors
National Institutes of Health (NIH)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction | 4 months | Measured with pre and post MRIs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Liver Stiffness | 4 months | Change in liver stiffness as measured using Magnetic resonance (MR) elastography |
| Body Weight Change | 4 months | Measured with change in body weight |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Diet and Lifestyle Program |
|---|---|
| Age, Continuous | 58.22 years STANDARD_DEVIATION 11.23 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 3 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction
Measured with pre and post MRIs
Time frame: 4 months
Population: We analyzed all participants with outcome data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet and Lifestyle Program | Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction | -7.06 percentage of liver lobe fat |
Secondary
Body Weight Change
Measured with change in body weight
Time frame: 4 months
Population: We analyzed all participants with outcome data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet and Lifestyle Program | Body Weight Change | -10.69 kg |
Secondary
Change in Liver Stiffness
Change in liver stiffness as measured using Magnetic resonance (MR) elastography
Time frame: 4 months
Population: We analyzed all participants with outcome data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet and Lifestyle Program | Change in Liver Stiffness | -0.33 kilopascals (kPa) |