NCT07285135 Dietary Glycine Supplementation in Metabolic Dysfunction-associated Steatotic Liver Disease
| NCT ID | NCT07285135 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Singapore General Hospital |
| Condition | Metabolic Dysfunction Associated Fatty Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-11-01 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to investigate abnormalities in glycine-dependent metabolic pathways in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and evaluate whether dietary glycine supplementation improves liver health and metabolic function. The study consists of two components. The first is a cross-sectional case-control study comparing urinary acylglycine concentrations and other glycine-dependent metabolic parameters between 60 participants with MASLD and 30 healthy controls. The second is a randomized, double-blind, placebo-controlled trial in which 60 participants with MASLD will receive either oral glycine supplementation (9 g/day) or placebo for 26 weeks. The primary outcomes are differences in urinary acylglycine concentrations between participants with MASLD and healthy controls, and changes in hepatic fat content measured by MRI-PDFF and urinary acylglycine concentrations following supplementation. Additional assessments will evaluate amino acid metabolism, glutathione metabolism, oxidative stress, inflammatory responses, and one-carbon metabolism-related biomarkers. Participants will undergo baseline, Week 12, and Week 26 assessments to evaluate metabolic changes and treatment responses.
Eligibility Criteria
Inclusion Criteria: All subjects: 1. Age 21-70 years 2. Ability to provide informed consent. MASLD group: 1. Hepatic steatosis on MRI 2. BMI of 25-50 kg/m2 Controls: 1. Absence of hepatic steatosis on MRI 2. BMI of 18.5-24.9 kg/m2 3. No chronic disease 4. No long-term medications Exclusion Criteria: 1. Uncontrolled diabetes (HbA1c \> 8%) 2. Type 1 Diabetes Mellitus 3. Clinically significant anemia (Haemoglobin \< 10 g/dL) 4. Chronic liver disorders (except MASLD) such as Hepatitis B, Hepatitis C, Wilson's disease, hemochromatosis, autoimmune hepatitis, chronic cholestatic disorders, and liver cirrhosis 5. Drugs that may induce hepatic steatosis, such as methotrexate, amiodarone, tamoxifen, or Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone) 6. Glomerular filtration rate (GFR \< 30 ml/min) 7. Serum alanine transaminase (ALT) \> 3x upper limit of normal (ULN) 8. Serum aspartate transaminase (AST) \> 3x ULN 9. Liver cirrhosis 10. Significant alcohol consumption (\> 20g/day for women and \>30g/day for men) 11. Pregnancy 12. Uncontrolled thyroid disease 13. Previous bariatric surgery 14. Weight loss \> 5% in the past 1 month 15. Metallic implants (including incompatible pacemakers, AICD, metallic heart valves) or other contraindications to MRI 16. Claustrophobia 17. Any factors likely to limit adherence to study protocol (e.g., dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other, or family members)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07285135 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 70 Years, studying Metabolic Dysfunction Associated Fatty Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07285135 currently recruiting?
Yes, NCT07285135 is actively recruiting participants. Contact the research team at tan.hong.chang@singhealth.com.sg for enrollment information.
Where is the NCT07285135 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT07285135 clinical trial?
NCT07285135 is sponsored by Singapore General Hospital. The trial plans to enroll 90 participants.