Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH
Verified date | December 2022 |
Source | Better Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This single arm interventional cohort study is designed to explore the feasibility of using BT-NCBT-00x to improve liver fat, inflammation, and stiffness in patients diagnosed with NAFLD or NASH over a 3 month intervention.
Status | Completed |
Enrollment | 22 |
Est. completion date | December 7, 2022 |
Est. primary completion date | November 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Diagnosis of NAFLD or NASH - At least 2 doses of the COVID-19 Vaccine, per self report - Possession of a smartphone capable of running the Bt_NCBT-00x application - BMI >/= 30 at the screening visit - Fibroscan CAP >300 dB/m collected at screening visit - Completion of baseline MRI-PDFF - Understand written and spoken english Exclusion Criteria: - Inability to read and understand english - unstable or life-threatening medical illness - weight loss of greater than 10lbs within the last 90 days - pregnant or planning to become pregnant women - concurrent enrollment in any other interventional clinical trial - presumed or confirmed COVID-19 diagnosis within 30 days prior to study enrollment - change in medication regimen of hormonal contraceptives, anti-hyperglycemic medications, mental or emotional disorder medications, corticosteroids, thyroid hormones, Tamoxifen or Methotrexate within 90 days |
Country | Name | City | State |
---|---|---|---|
United States | Arizona Liver Health | Chandler | Arizona |
United States | Arizona Liver Health | Peoria | Arizona |
Lead Sponsor | Collaborator |
---|---|
Better Therapeutics | Arizona Liver Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in percent liver fat | Mean change in percent liver fat from baseline to end of treatment in participants with baseline PDFF = 10%, as measured by MRI-PDFF. | 90 days | |
Secondary | Change in Liver Fat- all participants | Mean change in liver fat from baseline to end of treatment in all participants, as measured by MRI-PDFF | 90 days | |
Secondary | Reduction in Percent Liver fat | Percent of participants who achieve = 30% change in PDFF from baseline to end of treatment | 90 days |
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