NCT07285135Recruiting
Dietary Glycine Supplementation in Metabolic Dysfunction-associated Steatotic Liver Disease
Investigating the Effects of Dietary Glycine Supplementation in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 18 Nov 2025
- Start date
- 1 Nov 2025
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Singapore General Hospital
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07285135
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 1 Nov 2025 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drugs that may induce hepatic steatosis, such as methotrexate, amiodarone, tamoxifen, or Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)
- Previous bariatric surgery
Other illness
- Type 1 Diabetes Mellitus
- Chronic liver disorders (except MASLD) such as Hepatitis B, Hepatitis C, Wilson's disease, hemochromatosis, autoimmune hepatitis, chronic cholestatic disorders, and liver cirrhosis
- Uncontrolled thyroid disease
- Metallic implants (including incompatible pacemakers, AICD, metallic heart valves) or other contraindications to MRI
- 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)
Lab values
- Uncontrolled diabetes (HbA1c \> 8%)
- Clinically significant anemia (Haemoglobin \< 10 g/dL)
- Glomerular filtration rate (GFR \< 30 ml/min)
- Serum alanine transaminase (ALT) \> 3x upper limit of normal (ULN)
- Serum aspartate transaminase (AST) \> 3x ULN
Other
- Liver cirrhosis
- Significant alcohol consumption (\> 20g/day for women and \>30g/day for men)
- Pregnancy
- Weight loss \> 5% in the past 1 month
- Claustrophobia
Who the study is looking for
- All subjects:
- Age 21-70 years
- Ability to provide informed consent.
- MASLD group:
- Hepatic steatosis on MRI
- BMI of 25-50 kg/m2
- Controls:
- Absence of hepatic steatosis on MRI
- BMI of 18.5-24.9 kg/m2
- No chronic disease
- No long-term medications
Age in the registry: 21 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Singapore General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.