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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diet and lifestyle program | Behavioral | See description of main arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction | Measured with pre and post MRIs | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Liver Stiffness | Change in liver stiffness as measured using Magnetic resonance (MR) elastography | 4 months |
| Body Weight Change | Measured with change in body weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction | Measured with pre and post MRIs | We analyzed all participants with outcome data. | Posted | Mean | 95% Confidence Interval | percentage of liver lobe fat | 4 months |
|
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4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Saslow, Associate Professor | University of Michigan | (734) 764-7836 | saslowl@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 2, 2021 | Jun 6, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2022 | Sep 15, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| 4 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | Change in Liver Stiffness | Change in liver stiffness as measured using Magnetic resonance (MR) elastography | We analyzed all participants with outcome data. | Posted | Mean | 95% Confidence Interval | kilopascals (kPa) | 4 months |
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|
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| Secondary | Body Weight Change | Measured with change in body weight | We analyzed all participants with outcome data. | Posted | Mean | 95% Confidence Interval | kg | 4 months |
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| 0 |
| 11 |
| 0 |
| 11 |
| 3 |
| 11 |
| flare up of dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| broken foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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