Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT03784716
Status:
COMPLETED
Last Update Posted:
2022-05-11
First Post:
2018-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ketogenic Diet in Non-alcoholic Fatty Liver Disease
Sponsor:
Marc Goodman
Organization:
Study Overview
Official Title:
Ke-To Liver Health Study: A Randomized Controlled Trial to Study the Effects of a 28-day Ketogenic Dietary Intervention on Non-alcoholic Fatty Liver Disease Progression
Status:
COMPLETED
Status Verified Date:
2022-05
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:
The purpose of this randomized trial is to examine the effects of a ketogenic diet on non-alcoholic fatty liver disease (NAFLD). Twenty-four participants with NAFLD will be randomized to receive a ketogenic meal plan or control (standard weight loss meal plan). Participants will be followed up to 28 days after initiation of the diet intervention.
Detailed Description:
We will conduct a randomized trial to examine the effects of a ketogenic diet on non-alcoholic fatty liver disease (NAFLD). Twenty-four participants with NAFLD will be randomized into one of two groups: 12 participants will be randomized to receive a ketogenic meal plan and 12 participants will be randomized to receive a standard weight loss meal plan. There will be one screening visit and three study visits: the baseline visit, and follow-up visits 14 days and 28 days after initiation of the diet intervention. The study team hypothesizes that participants randomized to a ketogenic diet will have a greater reduction in intrahepatic triglycerides compared to those randomized to a standard weight loss diet.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: