Dietary Glycine Supplementation in Metabolic Dysfunction-associated Steatotic Liver Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorSingapore General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 21-70 years
Ability to provide informed consent.
Hepatic steatosis on MRI
BMI of 25-50 kg/m2
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Glycine
Dietary supplement9g/day of glycine in capsules
Placebo
Dietary supplementMicrocrystalline cellulose in identifically-looking capsules
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: GlycineActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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 weeks2
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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