Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-26 @ 5:16 PM
Study NCT ID:
NCT07285135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Glycine Supplementation in Metabolic Dysfunction-associated Steatotic Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005998', 'term': 'Glycine'}], 'ancestors': [{'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': 'From the initiation to end of the treatment at 26 weeks'}, {'measure': 'Differences in concentrations of acylglycines, glutathione, cytokines, oxidative stress markers, and 1-carbon cycle metabolites between subjects with MASLD and controls', 'timeFrame': 'From enrollment to the completion of baseline metabolic assessment (within 8 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fatty liver', 'Randomized controlled trial', 'glycine supplements'], 'conditions': ['Metabolic Dysfunction Associated Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': '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).\n\nThis 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.', 'detailedDescription': 'This study will recruit 60 participants with MASLD and 30 healthy controls.\n\nFollowing 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.\n\nStudy 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll subjects:\n\n1. Age 21-70 years\n2. Ability to provide informed consent.\n\nMASLD group:\n\n1. Hepatic steatosis on MRI\n2. BMI of 25-50 kg/m2\n\nControls:\n\n1. Absence of hepatic steatosis on MRI\n2. BMI of 18.5-24.9 kg/m2\n3. No chronic disease\n4. No long-term medications\n\nExclusion Criteria:\n\n1. Uncontrolled diabetes (HbA1c \\> 8%)\n2. Type 1 Diabetes Mellitus\n3. Clinically significant anemia (Haemoglobin \\< 10 g/dL)\n4. Chronic liver disorders (except MASLD) such as Hepatitis B, Hepatitis C, Wilson's disease, hemochromatosis, autoimmune hepatitis, chronic cholestatic disorders, and liver cirrhosis\n5. Drugs that may induce hepatic steatosis, such as methotrexate, amiodarone, tamoxifen, or Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)\n6. Glomerular filtration rate (GFR \\< 30 ml/min)\n7. Serum alanine transaminase (ALT) \\> 3x upper limit of normal (ULN)\n8. Serum aspartate transaminase (AST) \\> 3x ULN\n9. Liver cirrhosis\n10. Significant alcohol consumption (\\> 20g/day for women and \\>30g/day for men)\n11. Receiving weight loss medications or GLP-1 receptor agonists\n12. Pregnancy\n13. Uncontrolled thyroid disease\n14. Previous bariatric surgery\n15. Weight loss \\> 5% in the past 1 month\n16. Metallic implants (including incompatible pacemakers, AICD, metallic heart valves) or other contraindications to MRI\n17. Claustrophobia\n18. 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)"}, 'identificationModule': {'nctId': 'NCT07285135', 'briefTitle': 'Dietary Glycine Supplementation in Metabolic Dysfunction-associated Steatotic Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Singapore General Hospital'}, 'officialTitle': 'Investigating the Effects of Dietary Glycine Supplementation in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease', 'orgStudyIdInfo': {'id': '2025-1240'}, 'secondaryIdInfos': [{'id': 'CSAINV25jan-0007', 'type': 'OTHER', 'domain': 'NMRC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Glycine', 'description': '9g per day of glycine in capsules', 'interventionNames': ['Dietary Supplement: Glycine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Microcrystalline cellulose in capsules', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Glycine', 'type': 'DIETARY_SUPPLEMENT', 'description': '9g/day of glycine in capsules', 'armGroupLabels': ['Glycine']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Microcrystalline cellulose in identifically-looking capsules', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hong Chang Tan, MD PhD', 'role': 'CONTACT', 'email': 'tan.hong.chang@singhealth.com.sg', 'phone': '+65 63214658'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Beginning 3 months and ending 3 years after the publication of results', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}