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| Name | Class |
|---|---|
| Gencor Pacific Limited, Hong Kong | INDUSTRY |
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The goal of this clinical trial is to assess whether TRPTI (oleoylethanolamide) can improve glucose tolerance in healthy adults aged 18 years and above with BMI 18.5-29.9 kg/m². The main questions it aims to answer are:
Researchers will compare TRPTI 150 mg, TRPTI 300 mg, and placebo in a crossover design to see if TRPTI improves glucose metabolism and insulin sensitivity compared to placebo. Participants will complete 3 clinic visits (each lasting approximately 4 hours) with a minimum 6-day washout period between visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRPTI 150mg | Experimental | Single dose of 150mg TRPTI will be administered orally. |
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| TRPTI 300mg | Experimental | Single dose of 300mg TRPTI will be administered orally. |
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| Placebo | Placebo Comparator | Single dose of placebo will be administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRPTI 150mg | Dietary Supplement | Single dose of 150mg TRPTI will be orally administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Glucose Tolerance - AUC | Change from baseline to the end of the study period in Glucose AUC (0-120 min): Area under the curve for glucose concentration from 0-120 minutes post-glucose load | 0 to 120mins |
| Glucose - Peak glucose response | Change from baseline to the end of the study period in Peak glucose response - Maximum glucose concentration achieved during the test period. | 0 to 120minutes |
| Glucose Tolerance - Time to Peak Glucose | Change from baseline to the end of the study period in Time to peak glucose - Time point at which maximum glucose concentration occurs. | 0 to 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Response - AUC | Insulin AUC (0-120 min): Area under the curve for insulin concentration from 0-120 minutes post-glucose load | 0 to 120 minutes |
| Insulin Response - Peak insulin response |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability: AEs | Adverse events: Any untoward medical occurrences during the study period | Baseline to 3 hours |
| Safety and Tolerability - Blood pressure | Vital signs: Blood pressure at the start and end of each visit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| RV Venkatesh | Gencor Pacific | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical | Brisbane | Queensland | 4006 | Australia |
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| ID | Term |
|---|---|
| C488250 | oleoylethanolamide |
| C109691 | microcrystalline cellulose |
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Double-blind, randomised, placebo-controlled crossover study with 3 treatment arms
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| TRPTI 300mg | Dietary Supplement | Single dose of 300mg TRPTI will be orally administered. |
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| Placebo | Other | Single dose of placebo will be orally administered. |
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Peak insulin response: Maximum insulin concentration achieved during the test period
| 0 to 120 minutes |
| Insulin Response - HOMA-IR | HOMA-IR: Homeostatic Model Assessment of Insulin Resistance calculated from fasting glucose and insulin. | 0 minutes |
| Baseline to 3 hours |
| Safety and Tolerability - Heart rate | Vital signs: Heart rate at the start and end of each visit | Baseline to 3 hours |
| Safety and Tolerability - GIT Tolerance | GIT tolerance: Gastrointestinal Tolerance questionnaire assessing nausea, bloating, discomfort etc. | Baseline to 3 hours |
| Anthropometry - Weight | Weight at each visit | Baseline to week 3 |
| Anthropometry - BMI | BMI at each visit | Baseline to week 3 |