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Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

NCT05357248 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-12-13

No results posted yet for this study

Summary

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.

Conditions

  • Non-alcoholic Steatohepatitis
  • Non-Alcoholic Fatty Liver Disease
  • Non-alcoholic Fatty Liver

Interventions

DEVICE

BT-NCBT-00X

the intervention group will consist of 20 patients to receive the BT-NCBT-00X treatment for 90 days. They will receive a baseline MRI-PDFF, Fibroscan and have the tests repeated at 90 days.

Sponsors & Collaborators

  • Arizona Liver Health

    collaborator UNKNOWN

  • Better Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-10
Primary Completion
2022-11-11
Completion
2022-12-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05357248 on ClinicalTrials.gov