Dietary Glycine Supplementation in Metabolic Dysfunction-associated Steatotic Liver Disease

NCT07285135 | Not Yet Recruiting

• 2 other identifiers: 2025-1240CSAINV25jan-0007
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Dysfunction Associated Fatty Liver Disease

Keywords

Fatty liver; Randomized controlled trial; glycine supplements

Outcome Measures

Primary Outcomes (2)

• Changes in hepatic Magnetic Resonance Imaging-Proton Density Fat Fraction and concentrations of acylglycines, glutathione, cytokines, oxidative stress markers, and 1-carbon cycle metabolites from baseline to 26 weeks

  From the initiation to end of the treatment at 26 weeks

• Differences in concentrations of acylglycines, glutathione, cytokines, oxidative stress markers, and 1-carbon cycle metabolites between subjects with MASLD and controls

  From enrollment to the completion of baseline metabolic assessment (within 8 weeks)

Study Arms (2)

Glycine

ACTIVE COMPARATOR

9g per day of glycine in capsules

Dietary Supplement: Glycine

Placebo

PLACEBO COMPARATOR

Microcrystalline cellulose in capsules

Dietary Supplement: Placebo

Interventions

Glycine DIETARY_SUPPLEMENT

9g/day of glycine in capsules

Glycine

Placebo DIETARY_SUPPLEMENT

Microcrystalline cellulose in identifically-looking capsules

Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncontrolled diabetes (HbA1c \> 8%)
• Type 1 Diabetes Mellitus
• Clinically significant anemia (Haemoglobin \< 10 g/dL)
• Chronic liver disorders (except MASLD) such as Hepatitis B, Hepatitis C, Wilson's disease, hemochromatosis, autoimmune hepatitis, chronic cholestatic disorders, and liver cirrhosis
• Drugs that may induce hepatic steatosis, such as methotrexate, amiodarone, tamoxifen, or Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)
• Glomerular filtration rate (GFR \< 30 ml/min)
• Serum alanine transaminase (ALT) \> 3x upper limit of normal (ULN)
• Serum aspartate transaminase (AST) \> 3x ULN
• Liver cirrhosis
• Significant alcohol consumption (\> 20g/day for women and \>30g/day for men)
• Receiving weight loss medications or GLP-1 receptor agonists
• Pregnancy
• Uncontrolled thyroid disease
• Previous bariatric surgery
• Weight loss \> 5% in the past 1 month

Sponsors & Collaborators

• Singapore General Hospital: lead

MeSH Terms

Conditions

Fatty Liver

Interventions

Glycine

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Hong Chang Tan, MD PhD

CONTACT

+65 63214658; tan.hong.chang@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 16, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months and ending 3 years after the publication of results