[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658265":3},{"organization":4,"outcomesModule":7,"designInfo":89,"detailedDescription":92,"studyPopulation":92,"armGroups":101,"interventions":114,"overallOfficials":122,"centralContacts":127,"locations":133,"responsibleParty":152,"collaborators":154,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":92,"eligibilityCriteria":163,"healthyVolunteers":164,"sex":165,"minAge":166,"maxAge":92,"enrollmentInfo":167,"targetDuration":92,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":179,"whyStopped":92,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"RDC Clinical Pty Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in plasma GLP-1 concentration","Change from baseline in plasma GLP-1 concentration at each individual post-dose time point (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3, 4, 5, 6, 7, and 8-hours post-dose). Comparing TRPTI 150 mg to placebo","Baseline to 8hrs",[14,17,19,21,23,25,27,29,31,33,35,37,39,41,43,45,47,49,53],{"measure":15,"description":16,"timeFrame":12},"GLP-1 area under the curve (AUC)","GLP-1 area under the curve (AUC) 0: total (0-8 h) and pre-defined blocks (0-15 min, 15 min-2 h, 2-4 h, 4-6 h, 6-8 h). Comparing TRPTI 150 mg to placebo",{"measure":18,"description":18,"timeFrame":12},"Change from baseline at each individual time point for: GIP",{"measure":20,"description":20,"timeFrame":12},"Change from baseline at each individual time point for: DPP-4 (dipeptidyl peptidase-4)",{"measure":22,"description":22,"timeFrame":12},"Change from baseline at each individual time point for: glucose",{"measure":24,"description":24,"timeFrame":12},"Change from baseline at each individual time point for: insulin",{"measure":26,"description":26,"timeFrame":12},"AUC (total and blocks) for: GIP",{"measure":28,"description":28,"timeFrame":12},"AUC (total and blocks) for: DPP-4",{"measure":30,"description":30,"timeFrame":12},"AUC (total and blocks) for: glucose",{"measure":32,"description":32,"timeFrame":12},"AUC (total and blocks) for: insulin",{"measure":34,"description":34,"timeFrame":12},"Tmax for GLP-1",{"measure":36,"description":36,"timeFrame":12},"Tmax for DPP-4",{"measure":38,"description":38,"timeFrame":12},"Tmax for glucose",{"measure":40,"description":40,"timeFrame":12},"Tmax for insulin",{"measure":42,"description":42,"timeFrame":12},"Cmax for GLP-1",{"measure":44,"description":44,"timeFrame":12},"Cmax for DPP-4",{"measure":46,"description":46,"timeFrame":12},"Cmax for glucose",{"measure":48,"description":48,"timeFrame":12},"Cmax for insulin",{"measure":50,"description":51,"timeFrame":52},"Tolerability including GIT tolerance","Tolerability including gastrointestinal (GIT) tolerance will be measured via a Gastronintestinal tolerance questionnaire and GIT adverse events.","Baseline to 8 hours",{"measure":54,"description":54,"timeFrame":52},"Safety via AE monitoring",[56,58,60,63,66,69,72,74,76,79,82,85],{"measure":57,"description":57,"timeFrame":52},"Exploratory: Change from baseline at each individual time point for glucagon",{"measure":59,"description":59,"timeFrame":52},"Exploratory: Change from baseline at each individual time point for PYY (peptide YY)",{"measure":61,"description":62,"timeFrame":52},"Exploratory: AUC (total and blocks) for glucagon","AUC (total and blocks) for glucagon",{"measure":64,"description":65,"timeFrame":52},"Exploratory: AUC (total and blocks) for PYY","AUC (total and blocks) for PYY",{"measure":67,"description":68,"timeFrame":52},"Exploratory: Tmax for glucagon","Tmax for glucagon",{"measure":70,"description":71,"timeFrame":52},"Exploratory: Tmax for PYY","Tmax for PYY",{"measure":73,"description":68,"timeFrame":52},"Exploratory: Cmax for glucagon",{"measure":75,"description":71,"timeFrame":52},"Exploratory: Cmax for PYY",{"measure":77,"description":78,"timeFrame":12},"Exploratory: Visual analogue scale (VAS) for appetite","VAS for appetite",{"measure":80,"description":81,"timeFrame":52},"Exploratory: Food consumption during time in clinic","Food consumption during time in clinic",{"measure":83,"description":84,"timeFrame":52},"Exploratory: E\u002FLFT","Blood sample taken for E\u002FLFT",{"measure":86,"description":87,"timeFrame":88},"Exploratory: Subgroup analysis by BMI stratum","Subgroup analysis by BMI stratum (BMI 25.0-29.9 vs BMI 30.0-34.9).","Baseline",{"allocation":90,"interventionModel":91,"interventionModelDescription":92,"primaryPurpose":93,"observationalModel":92,"timePerspective":92,"maskingInfo":94},"RANDOMIZED","CROSSOVER",null,"OTHER",{"masking":95,"maskingDescription":92,"whoMasked":96},"QUADRUPLE",[97,98,99,100],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[102,108],{"label":103,"type":104,"description":105,"interventionNames":106},"TRPTI","EXPERIMENTAL","Participants will receive a single capsule of 150mg TRPTI",[107],"Dietary Supplement: TRPTI",{"label":109,"type":110,"description":111,"interventionNames":112},"Placebo","PLACEBO_COMPARATOR","Participants will receive a single capsule of placebo",[113],"Other: Placebo",[115,120],{"type":116,"name":103,"description":105,"armGroupLabels":117,"otherNames":118},"DIETARY_SUPPLEMENT",[103],[119],"Oleoylethanolamide",{"type":93,"name":109,"description":111,"armGroupLabels":121,"otherNames":92},[109],[123],{"name":124,"affiliation":125,"role":126},"RV Venkatesh","Gencor Pacific","STUDY_DIRECTOR",[128],{"name":129,"role":130,"phone":131,"phoneExt":92,"email":132},"David Briskey","CONTACT","+61(0)731024486","research@rdcglobal.com.au",[134],{"facility":135,"status":92,"city":136,"state":137,"zip":138,"country":139,"countryCode":140,"cosmosGeoPoint":141,"geoPoint":146,"contacts":147},"RDC Clinical","Fortitude Valley","Queensland","4006","Australia","AU",{"type":142,"coordinates":143},"Point",[144,145],153.03178,-27.45706,{"lat":145,"lon":144},[148,150],{"name":129,"role":130,"phone":149,"phoneExt":92,"email":132},"+61 (0) 731024486",{"name":129,"role":151,"phone":92,"phoneExt":92,"email":92},"PRINCIPAL_INVESTIGATOR",{"type":153,"investigatorFullName":92,"investigatorTitle":92,"investigatorAffiliation":92,"oldNameTitle":92,"oldOrganization":92},"SPONSOR",[155],{"name":156,"class":6},"Gencor Pacific Limited, Hong Kong","100658265","phase-4-trpti-metabolic-and-glp-1-pharmacodynamic-study-100658265",false,"NCT07850466","TRPTI Metabolic and GLP-1 Pharmacodynamic Study","Short-term Effect of TRPTI Supplementation on GLP-1 and Related Metabolic Markers in Overweight or Obese Adults - a Double-blind, Randomised, Placebo-controlled, Two-arm Cross-over Study","Inclusion Criteria:\n\n* Adults aged 30 years and older\n* Generally healthy\n* BMI 25.0-34.9 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* Females using a prescribed form of birth control (e.g., oral contraceptive)\n* Participant's ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points\n* Able to attend the clinic on all required days\n\nExclusion Criteria:\n\n* Have a serious illness e.g., neurological disorders such as MS, kidney disease, liver disease or heart conditions\n* History of any glucose or insulin regulation problem, including diabetes\n* Have an unstable illness e.g., thyroid gland dysfunction, uncontrolled mood disorders (e.g., depression, anxiety, bipolar)\n* Diagnosed with any known metabolic or endocrine dysfunctions e.g., diabetes, NAFLD, hyperinsulinaemia, hypoglycaemia\n* Use of any medication or supplements that may affect any metabolic pathway associated with satiety (e.g., GLP-1, GIP, glucagon), glucose or insulin\n* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years\n* Significant change in diet in the past 1 month (e.g., removal of a food group or calorie restriction)\n* Active smokers, nicotine use or drug (prescription or illegal substances) abuse\n* Chronic past and\u002For current alcohol use (\\>21 alcoholic drinks\u002Fweek)\n* Pregnant or lactating women\n* Allergic to any of the ingredients in active or placebo formula\n* Participants who are or who have participated in any other clinical trial during the past 1 month (excludes RDC clinical trials which are to be assessed on a case-by-case basis)\n* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion\n* Regular use within the past 4 weeks of supplements containing OEA and LipiSperse (TRPTITM)",true,"ALL","30 Years",{"count":168,"type":169},20,"ESTIMATED","INTERVENTIONAL",[172],"PHASE4","The goal of this clinical trial is to assess whether TRPTI™ supplementation affects GLP-1 and related metabolic markers in generally healthy adults who are overweight or obese (BMI 25.0-34.9 kg\u002Fm², aged 30 years and older).\n\nResearchers will compare TRPTI™ 150 mg to a matching placebo capsule to see if TRPTI™ produces a meaningful difference in GLP-1 response and associated metabolic and appetite-related markers over 8 hours.\n\nParticipants will attend two 9-hour clinic visits (crossover design, with a minimum 6-day washout between visits).",[175],"Overweight , Obesity",[177,178],"metabolic markers","GLP-1","NOT_YET_RECRUITING","2026-09-24",{"date":182,"type":183},"2026-09-30","ACTUAL",{"date":185,"type":169},"2026-10",{"date":187,"type":169},"2027-10",{"name":5,"class":6},1]