Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04899102
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2021-05-19
Brief Title:
Intermittent Fasting for NAFLD in Adults
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Pilot Study of Time-Restricted Intermittent Fasting for Non-Alcoholic Fatty Liver Disease in Non-Obese Adults
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
NAFLD is a growing threat to public health Currently there is a significant need for highly effective treatments for NAFLD Non-obese NAFLD BMI30kgm2 is an increasingly recognized condition sometimes described as lean NAFLD Intermittent Fasting IF may be uniquely beneficial in non-obese NAFLD The purpose of this study is to identify non-pharmacologic lifestyle-based methods of NAFLD treatment within non-obese adults
Detailed Description:
Nonalcoholic fatty liver disease NAFLD which encompasses a spectrum from simple steatosis and steatohepatitis NASH to fibrosis and cirrhosis is the leading cause of liver disease in the United States There are currently no FDA-approved pharmacologic therapies for NAFLD and NASH and standard low-calorie diets are often minimally effective difficult to adhere to and to maintain Thus continued investigation of strategies to treat NAFLD and NASH is greatly needed Non-obese NAFLD BMI30kgm2 is an increasingly recognized condition sometimes described as lean NAFLD It is estimated that 10-20 of American and Europeans without obesity have this condition There is a pressing need for the study of lifestyle interventions independent of weight loss to treat this important subset of NAFLD patients This protocol aims to investigate the utility of time restricted intermittent fasting TRF as a potential method Adults with non-obese NAFLD are at risk of progression to end-stage liver disease and development of cardiometabolic disease Intermittent Fasting IF may be uniquely beneficial in non-obese NAFLD IF is characterized by periods of dietary restriction leading to metabolic production and use of ketones from adipocytes rather than hepatically-derived glucose
The goal of this study is to learn if time-restricted intermittent fasting can help reduce the amount of fat in the liver in adults with non-alcoholic fatty liver disease NAFLD Ideally this study will yield more information about time-restricted intermittent fasting as a potential lifestyle-based treatment for adults with NAFLD and a body mass index BMI between 23-30 kgm2
The goal of this study is to learn if time-restricted intermittent fasting can help reduce the amount of fat in the liver in adults with non-alcoholic fatty liver disease NAFLD Ideally this study will yield more information about time-restricted intermittent fasting as a potential lifestyle-based treatment for adults with NAFLD and a body mass index BMI between 23-30 kgm2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None