[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628137":3},{"organization":4,"outcomesModule":7,"designInfo":91,"detailedDescription":96,"studyPopulation":96,"armGroups":104,"interventions":117,"overallOfficials":128,"centralContacts":133,"locations":139,"responsibleParty":159,"collaborators":161,"id":164,"slug":96,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":171,"sex":172,"minAge":173,"maxAge":96,"enrollmentInfo":174,"targetDuration":96,"studyType":177,"phases":178,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":185,"whyStopped":96,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},{"fullName":5,"class":6},"RDC Clinical Pty Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":53},[9],{"measure":10,"description":11,"timeFrame":12},"Imidazole Propionate (ImP)","Plasma ImP concentration: Primary metabolite produced by histidine-metabolizing gut bacteria, strongly associated with insulin resistance and type 2 diabetes risk Change from baseline: Reduction in ImP levels indicating improved metabolic health","Baseline to week 8",[14,17,20,23,26,29,32,35,38,41,44,47,50],{"measure":15,"description":16,"timeFrame":12},"Gut Microbiome Composition","Gut microbiome composition and functional capacity will be assessed from stool samples using 16S rRNA gene sequencing and metagenomic sequencing. Analyses will evaluate overall microbial community structure, relative abundance of histidine-metabolising bacteria, and functional pathways related to imidazole propionate production.\n\nMeasurement details:\n\nAnalytical method: 16S rRNA gene sequencing and shotgun metagenomic sequencing Units: Relative abundance (%), diversity indices (unitless), and pathway abundance (relative abundance)",{"measure":18,"description":19,"timeFrame":12},"Histidine Metabolic Pathway - Histidine","Histidine: Precursor amino acid for ImP synthesis. Plasma histidine concentration will be quantified as a marker of substrate availability within the histidine metabolic pathway.",{"measure":21,"description":22,"timeFrame":12},"Histidine Metabolic Pathway - Histamine","Histamine: Alternative histidine metabolite. Plasma histamine concentration will be measured as an alternative downstream metabolite of histidine metabolism.",{"measure":24,"description":25,"timeFrame":12},"Histidine Metabolic Pathway - Urocanic acid","Urocanic acid: Intermediate metabolite in histidine degradation pathway. Plasma urocanic acid concentration (µmol\u002FL), an intermediate metabolite in the histidine degradation pathway, will be quantified.",{"measure":27,"description":28,"timeFrame":12},"Insulin Sensitivity and Metabolic Health: HOMA-IR","Insulin sensitivity and beta-cell function will be assessed using the Homeostatic Model Assessment (HOMA). Indices will be calculated from fasting plasma glucose and fasting serum insulin concentrations.\n\nSpecific indices derived:\n\n* HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) HOMA indices derived using the HOMA2 model calculator (Oxford Centre for Diabetes, Endocrinology and Metabolism",{"measure":30,"description":31,"timeFrame":12},"Insulin Sensitivity and Metabolic Health: HOMA2","Insulin sensitivity and beta-cell function will be assessed using the Homeostatic Model Assessment (HOMA). Indices will be calculated from fasting plasma glucose and fasting serum insulin concentrations.\n\nSpecific indices derived:\n\n* HOMA2-%B (beta-cell function) using the HOMA2 calculator HOMA indices derived using the HOMA2 model calculator (Oxford Centre for Diabetes, Endocrinology and Metabolism",{"measure":33,"description":34,"timeFrame":12},"Insulin Sensitivity and Metabolic Health: Lipid profile","Triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and HDL\u002FLDL ratio",{"measure":36,"description":37,"timeFrame":12},"Insulin Sensitivity and Metabolic Health: Homocysteine","Homocysteine",{"measure":39,"description":40,"timeFrame":12},"Safety and Tolerability - Adverse events","Adverse events: Any untoward medical occurrences during the study period",{"measure":42,"description":43,"timeFrame":12},"Safety and Tolerability - Blood pressure","Safety and tolerability, vital signs - blood pressure",{"measure":45,"description":46,"timeFrame":12},"Safety and Tolerability - Heart Rate","Safety and tolerability, vital signs - heart rate",{"measure":48,"description":49,"timeFrame":12},"Safety and Tolerability - E\u002FLFT (electrolytes)","Safety and tolerability biomarkers - Electrolytes Tests. These analytes form part of a single standard clinical chemistry panel (E\u002FLFT) performed as one laboratory assessment for safety monitoring rather than independent mechanistic endpoints.\n\nA comprehensive clinical chemistry panel will be used to assess E\u002FLFTs. The panel will be performed as a single laboratory assessment using standard automated clinical chemistry methods in an accredited pathology laboratory.",{"measure":51,"description":52,"timeFrame":12},"Safety and Tolerability - E\u002FLFT (Liver Function test)","Safety and tolerability biomarkers - Liver Function Tests. These analytes form part of a single standard clinical chemistry panel (E\u002FLFT) performed as one laboratory assessment for safety monitoring rather than independent mechanistic endpoints.\n\nA comprehensive clinical chemistry panel will be used to assess E\u002FLFTs. The panel will be performed as a single laboratory assessment using standard automated clinical chemistry methods in an accredited pathology laboratory.",[54,58,61,64,67,70,73,76,79,82,85,88],{"measure":55,"description":56,"timeFrame":57},"Other: Anthropometrics","Anthropometrics provide demographics information and context for metabolic outcomes (e.g., HOMA indices) and help interpret whether any biochemical changes could be partly explained by changes or differences in body mass over the 8-week period. Measures include Height, weight and BMI, hip and waist circumference.","Screening to week 8",{"measure":59,"description":60,"timeFrame":12},"Exploratory: Longevity markers","Changes over 8 weeks in longevity markers - Sirtuins (SIRTs)",{"measure":62,"description":63,"timeFrame":12},"Exploratory: Methylation status","Changes over 8 weeks in methylation status",{"measure":65,"description":66,"timeFrame":12},"Exploratory: Phenotypic clock","Changes in 8 weeks in phenotypic clock",{"measure":68,"description":69,"timeFrame":12},"Exploratory: High-sensitivity C-reactive protein","Changes over 8 weeks in High-sensitivity C-reactive protein (hs-CRP)",{"measure":71,"description":72,"timeFrame":12},"Exploratory: Full Blood count","Changes over 8 weeks in Full blood count",{"measure":74,"description":75,"timeFrame":12},"Exploratory: Nicotinamide adenine dinucleotide","Changes over 8 weeks in Nicotinamide adenine dinucleotide (NAD+)",{"measure":77,"description":78,"timeFrame":12},"Exploratory: reduced nicotinamide adenine dinucleotide","Changes over 8 weeks in reduced nicotinamide adenine dinucleotide (NADH)",{"measure":80,"description":81,"timeFrame":12},"Exploratory: Apolipoprotein B (ApoB)","Changes over 8 weeks in Apolipoprotein B (ApoB)",{"measure":83,"description":84,"timeFrame":12},"Exploratory: Interleukin (IL)-6","Changes over 8 weeks in Interleukin (IL)-6",{"measure":86,"description":87,"timeFrame":12},"Exploratory: Adiponectin","Changes over 8 weeks in Adiponectin",{"measure":89,"description":90,"timeFrame":12},"Exploratory: Genome-wide DNA methylation","Changes over 8 weeks in Genome-wide DNA methylation (CpG methylation patterns and epigenetic clock)",{"allocation":92,"interventionModel":93,"interventionModelDescription":94,"primaryPurpose":95,"observationalModel":96,"timePerspective":96,"maskingInfo":97},"RANDOMIZED","PARALLEL","Double-blind, randomised, placebo-controlled parallel study with 2 treatment groups","TREATMENT",null,{"masking":98,"maskingDescription":96,"whoMasked":99},"QUADRUPLE",[100,101,102,103],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[105,111],{"label":106,"type":107,"description":108,"interventionNames":109},"TRPTI 300mg","EXPERIMENTAL","Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg.",[110],"Dietary Supplement: TRPTI 300mg",{"label":112,"type":113,"description":114,"interventionNames":115},"Placebo","PLACEBO_COMPARATOR","Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg.",[116],"Other: Placebo",[118,124],{"type":119,"name":106,"description":120,"armGroupLabels":121,"otherNames":122},"DIETARY_SUPPLEMENT","Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg",[106],[123],"Oleoylethanolamide",{"type":125,"name":112,"description":126,"armGroupLabels":127,"otherNames":96},"OTHER","Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg",[112],[129],{"name":130,"affiliation":131,"role":132},"RV Venkatesh","Gencor Pacific","STUDY_DIRECTOR",[134],{"name":135,"role":136,"phone":137,"phoneExt":96,"email":138},"Amanda Rao","CONTACT","+61 (0) 7 3102 4486","research@rdcglobal.com.au",[140],{"facility":141,"status":96,"city":142,"state":143,"zip":144,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":152,"contacts":153},"RDC Clinical","Brisbane","Queensland","4006","Australia","AU",{"type":148,"coordinates":149},"Point",[150,151],153.02809,-27.46794,{"lat":151,"lon":150},[154,157],{"name":155,"role":136,"phone":156,"phoneExt":96,"email":138},"Amanda Rao, PhD","+61 (07) 3102 4486",{"name":155,"role":158,"phone":96,"phoneExt":96,"email":96},"PRINCIPAL_INVESTIGATOR",{"type":160,"investigatorFullName":96,"investigatorTitle":96,"investigatorAffiliation":96,"oldNameTitle":96,"oldOrganization":96},"SPONSOR",[162],{"name":163,"class":6},"Gencor Pacific Limited, Hong Kong","100628137",false,"NCT07457723","Gut Microbiome and Metabolic Health Study","A Double-blind, Randomised, Placebo-controlled Parallel Study to Assess the Effectiveness of TRPTI (Oleoylethanolamide) Compared to Placebo on Gut Microbiome and Plasma Biomarker Changes in Healthy Adults","IMPTRP","Inclusion Criteria:\n\n* Adults aged 18 years and above\n* Generally healthy\n* BMI 18.5-29.9 kg\u002Fm2\n* Able to provide informed consent\n* Agree to not participate in another clinical trial while enrolled in this trial\n* Agree not to change current diet and\u002For exercise frequency or intensity during entire study period\n* Stable diet and lifestyle for at least 4 weeks prior\n* Females using a prescribed form of birth control (e.g. oral contraceptive)\n\nExclusion Criteria:\n\n* Unstable or serious illness (e.g. Serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, thyroid gland dysfunction)\n* Known gastrointestinal disorders (IBD, IBS, celiac disease, etc.)\n* Use of antibiotics within 8 weeks prior to study entry\n* Regular use of medications that significantly affect gut microbiome (PPIs, laxatives, antacids)\n* Use of probiotics, prebiotics, or symbiotic within 4 weeks prior to study entry\n* Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years\n* Active smokers, nicotine use, alcohol or drug (prescription or illegal substances) abuse\n* Chronic past and\u002For current alcohol use (\\>14 alcoholic drinks week)\n* Allergic to any of the ingredients in the active or placebo formula\n* Consistently (3 or more days per week) taken OEA within 4 weeksb prior to study entry\n* Known pregnant or lactating woman\n* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion\n* Participants who have participated in any other non-RDC related clinical study during the past 1 month\n* History of infection in the month prior to the study",true,"ALL","18 Years",{"count":175,"type":176},90,"ESTIMATED","INTERVENTIONAL",[179],"PHASE2","The goal of this clinical trial is to assess whether TRPTI (oleoylethanolamide) can reduce plasma imidazole propionate levels and improve insulin sensitivity and metabolic health in healthy adults aged 18 years and above with BMI 18.5-29.9 kg\u002Fm². The main question it aims to answer is does TRPTI reduce plasma imidazole propionate (a gut microbiota-derived metabolite linked to insulin resistance)?\n\nResearchers will compare TRPTI 300 mg to placebo in a parallel design to see if TRPTI reduces imidazole propionate levels and improves metabolic health markers compared to placebo.\n\nParticipants will:\n\n* Take 2 capsules of their assigned study product daily for 8 consecutive weeks\n* Attend 3 clinic visits (at baseline, week 4 and week 8)",[182],"Healthy Volunteers",[184],"Gut microbiome","NOT_YET_RECRUITING","2026-05-07",{"date":188,"type":189},"2026-05-12","ACTUAL",{"date":191,"type":176},"2026-05",{"date":193,"type":176},"2027-03",{"name":5,"class":6},1]