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Not yet recruitingNCT07285135Updated Dec 16, 2025

Dietary Glycine Supplementation in Metabolic Dysfunction-associated Steatotic Liver Disease

An interventional study of Glycine and Placebo in Metabolic Dysfunction Associated Fatty Liver Disease, sponsored by Singapore General Hospital. Not yet recruiting. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by Singapore General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Metabolic Dysfunction Associated Fatty Liver Disease

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Keywords

  • Fatty liver
  • Randomized controlled trial
  • glycine supplements
03

In context

Fatty Liver

1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 1,003 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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. Receiving weight loss medications or GLP-1 receptor agonists
  12. Pregnancy
  13. Uncontrolled thyroid disease
  14. Previous bariatric surgery
  15. Weight loss > 5% in the past 1 month
  16. Metallic implants (including incompatible pacemakers, AICD, metallic heart valves) or other contraindications to MRI
  17. Claustrophobia
  18. 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Glycine

    9g per day of glycine in capsules

    Dietary Supplement: Glycine

  • Placebo comparator
    Placebo

    Microcrystalline cellulose in capsules

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementGlycine

    9g/day of glycine in capsules

  • Dietary supplementPlacebo

    Microcrystalline cellulose in identifically-looking capsules

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: From the initiation to end of the treatment at 26 weeks

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

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07285135
Lead sponsor
Singapore General Hospital
Responsible party
Sponsor
First posted
Dec 16, 2025
Start date
Dec 2025 (estimated)
Primary completion
Jul 2028 (estimated)
Completion
Jan 2029 (estimated)
Last update
Dec 16, 2025

Study contacts

Hong Chang Tan, MD PhD
Contact
tan.hong.chang@singhealth.com.sg
+65 63214658

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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