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Dietary Glycine Supplementation in Metabolic Dysfunction-associated Steatotic Liver Disease

RecruitingNAAges 21 Years - 70 YearsAllSingapore General Hospital
NCT07285135 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 acylgl

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📋 Eligibility rules (as published)
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)
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What it tests

  • Glycine
  • Placebo
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Where

1 site
Singapore General Hospital
Singapore, Singapore
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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