Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-03 @ 11:04 PM
Study NCT ID:
NCT07285135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Glycine Supplementation in Metabolic Dysfunction-associated Steatotic Liver Disease
Sponsor:
Singapore General Hospital
Organization:
Study Overview
Official Title:
Investigating the Effects of Dietary Glycine Supplementation in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
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 research study is to determine whether taking glycine, a naturally occurring amino acid, as a supplement improves liver health measurements in individuals with Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD).
This project will be divided into two parts. The first part will be a case-control study comparing parameters of glycine-dependent metabolic pathways between individuals with MASLD and healthy controls. The second part will be a randomized placebo-controlled trial (RCT) to evaluate the impact of 26-week dietary glycine supplementation on parameters of liver health versus 26-week placebo in patients with MASLD.
This project will be divided into two parts. The first part will be a case-control study comparing parameters of glycine-dependent metabolic pathways between individuals with MASLD and healthy controls. The second part will be a randomized placebo-controlled trial (RCT) to evaluate the impact of 26-week dietary glycine supplementation on parameters of liver health versus 26-week placebo in patients with MASLD.
Detailed Description:
This study will recruit 60 participants with MASLD and 30 healthy controls.
Following written informed consent, subjects will be screened. Eligible study subjects will return to undergo MRI scans of the abdomen to measure fat, iron, fibro-inflammation in the liver. Baseline metabolic measurements will include clinical laboratory tests, anthropometrics, body composition, resting energy expenditure, and comprehensive metabolomic profiling. Medical history, physical activity, dietary intake, and sleep quality will also be documented.
Study subjects in with MASLD will be randomized to consume either 9g/day of glycine capsules or placebo capsules for the next 26 ± 4 weeks. Subjects MASLD will be reviewed at 12 ± 4 weeks following the initiation of glycine or placebo to monitor compliance and adverse events.
The final study visit (for subjects with MASLD) will be scheduled at 26 ± 4 weeks after initiation of glycine or placebo. The study subjects will undergo metabolic measurements similar to those performed during the baseline visit.
Following written informed consent, subjects will be screened. Eligible study subjects will return to undergo MRI scans of the abdomen to measure fat, iron, fibro-inflammation in the liver. Baseline metabolic measurements will include clinical laboratory tests, anthropometrics, body composition, resting energy expenditure, and comprehensive metabolomic profiling. Medical history, physical activity, dietary intake, and sleep quality will also be documented.
Study subjects in with MASLD will be randomized to consume either 9g/day of glycine capsules or placebo capsules for the next 26 ± 4 weeks. Subjects MASLD will be reviewed at 12 ± 4 weeks following the initiation of glycine or placebo to monitor compliance and adverse events.
The final study visit (for subjects with MASLD) will be scheduled at 26 ± 4 weeks after initiation of glycine or placebo. The study subjects will undergo metabolic measurements similar to those performed during the baseline visit.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CSAINV25jan-0007 | OTHER | NMRC | View |