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| Name | Class |
|---|---|
| Gencor Pacific Limited, Hong Kong | INDUSTRY |
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A placebo controlled, single blind, cross-over study evaluating the short-term effect of oleoylethanolamide (OEA) with LipiSperse supplementation on metabolic pathways in healthy participants.
This study aims to compare the metabolic effects of two different doses of OEA with LipiSperse to a placebo in healthy participants over an 8-hour period. There are three trial arms in this study. Each participant will complete all 3 arms of the study, for a 3-way cross-over.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single dose of 2 capsules will be administered that appear identical to active arms. |
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| 125mg OEA with LipiSperse | Experimental | Single dose of 2 capsules will be administered. 1 capsule will contain 125mg OEA and 13.9mg of LipiSperse and 1 capsule will be a placebo. |
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| 250mg OEA with LipiSperse | Experimental | Single dose of 2 capsules will be administered. Each capsule will contain 125mg OEA and 13.9mg of LipiSperse. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Single dose of 2 capsules. Capsules contain the same excipients as the active arms, except for the OEA with LipiSperse in capsules that appear identical to the OEA with LipiSperse capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum/plasma GLP-1 AUC | Change from baseline to the end of the study period in serum/plasma GLP-1 AUC for each arm of treatment. | Baseline and 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum/plasma GIP AUC | Change from baseline to the end of the study period in serum/plasma GIP AUC for each of the 3 arms. | Baseline and 8 hours |
| Changes in serum/plasma DPP-4 AUC | Change from baseline to the end of the study period in serum/plasma DPP-4 AUC for each of the 3 arms. |
| Measure | Description | Time Frame |
|---|---|---|
| E/LFT for triglycerides, cholesterol and safety markers | Electrolyte/Liver Function Test (E/LFT) for triglycerides, cholesterol and safety markers for each arm. Samples will be analysed for a range of safety biomarkers within the E/LFT including Sodium, Potassium, Chloride, Bicarbonate, Calcium. | Baseline and 8 hours |
Inclusion Criteria:
Exclusion Criteria:
Males and Females who are cisgender
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| Name | Affiliation | Role |
|---|---|---|
| Ramasamy Venkatesh | Gencor Pacific | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical | Brisbane | Queensland | 4006 | Australia |
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| ID | Term |
|---|---|
| C000707817 | oleoyl ethanolamine |
| C488250 | oleoylethanolamide |
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| 125mg OEA with LipiSperse | Dietary Supplement | Single dose of 2 capsules. 1 capsule contains 125mg of OEA and 13.9mg of LipiSperse, the other capsule is a placebo. |
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| 250mg OEA with LipiSperse | Dietary Supplement | Single dose of 2 capsules. Each capsule contains 125mg of OEA and 13.9mg of LipiSperse. |
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| Baseline and 8 hours |
| Changes in serum/plasma glucagon AUC | Change from baseline to the end of the study period in serum/plasma glucagon AUC for each of the 3 arms. | Baseline and 8 hours |
| Changes in serum/plasma glucose AUC | Change from baseline to the end of the study period in serum/plasma glucose AUC for each of the 3 arms. | Baseline and 8 hours |
| Changes in serum/plasma insulin AUC | Change from baseline to the end of the study period in serum/plasma insulin AUC for each of the 3 arms. | Baseline and 8 hours |
| Tmax of GLP-1 | Tmax of GLP-1 for each of the 3 arms. | Baseline to 8 hours |
| Tmax of GIP | Tmax of GIP for each of the 3 arms. | Baseline to 8 hours |
| Tmax of DPP-4 | Tmax of DPP-4 for each of the 3 arms. | Baseline to 8 hours |
| Tmax of glucagon | Tmax of glucagon for each of the 3 arms. | Baseline to 8 hours |
| Tmax of glucose | Tmax of glucose for each of the 3 arms. | Baseline to 8 hours |
| Tmax of insulin | Tmax of insulin for each of the 3 arms. | Baseline to 8 hours |
| Cmax of GLP-1 | Cmax of GLP-1 for each of the 3 arms. | Baseline to 8 hours |
| Cmax of GIP | Cmax of GIP for each of the 3 arms. | Baseline to 8 hours |
| Cmax of DPP-4 | Cmax of DPP-4 for each of the 3 arms. | Baseline to 8 hours |
| Cmax of glucagon | Cmax of glucagon for each of the 3 arms. | Baseline to 8 hours |
| Cmax of glucose | Cmax of glucose for each of the 3 arms. | Baseline to 8 hours |
| Cmax of insulin | Cmax of insulin for each of the 3 arms. | Baseline to 8 hours |
| Individual absorption data for each subject | Individual change data obtained for serum/plasma GLP-1, GIP, DPP-4, glucagon, glucose and insulin from each participant for each of the 3 study arms will be individually compared for change. Individual results will then be combined for whole group comparison/analysis. | Baseline to 8 hours |
| Tolerability including GIT tolerance | Tolerability including Gastrointestinal (GIT) tolerance. A GIT tolerance questionnaire will be administered prior to lunch. Will be reviewed for each of the 3 arms | Baseline to 8 hours |
| Safety via AE monitoring | Safety via AE monitoring for each of the 3 arms | Baseline to 8hours post dose |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GLP-1) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in GLP-1 over 8-hours | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GIP) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in GIP over 8-hours | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in DPP-4) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in DPP-4 over 8-hours | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucagon) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in glucagon over 8-hours | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucose) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in glucose over 8-hours | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in insulin) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in insulin over 8-hours | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GLP-1) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of GLP-1 over 8-hours | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GIP) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of GIP over 8-hours | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of DPP-4) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of DPP-4 over 8-hours | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucagon) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of glucagon over 8-hours | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucose) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of glucose over 8-hours | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of insulin) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of insulin over 8-hours | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GLP-1) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of GLP-1 over 8-hours. | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GIP) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for GIP over 8-hours. | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of DPP-4) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of DPP-4 over 8-hours. | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucagon) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of glucagon over 8-hours. | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucose) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of glucose over 8-hours. | Baseline to 8 hours |
| Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of insulin) | Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of insulin over 8-hours. | Baseline to 8 hours |
| VAS for appetite | A visual analogue scale (VAS) for appetite will be administered 3.5 - 4 hours after dosing, and will be assessed for each of the 3 arms. | Baseline to 4 hours |
| Food consumption during the time in clinic (Lunch) | Participants will be supplied with a standardised lunch meal of known nutritional value (i.e., calories, carbohydrate, fat and protein content). Each participants food will be provided to them via a standardised container (i.e., the same dimension with foods segregated). Prior to and upon completion of the meal, all meal containers will be photographed. The photos will be used to assess the percentage of food that was consumed at each of the 3 visits. | Baseline to 8 hours. |
| Food consumption during the time in clinic (Breakfast) | Participants will be supplied with a standardised breakfast meal of known nutritional value (i.e., calories, carbohydrate, fat and protein content). Each participants food will be provided to them via a standardised container (i.e., the same dimension with foods segregated). Prior to and upon completion of the meal, all meal containers will be photographed. The photos will be used to assess the percentage of food that was consumed at each of the 3 visits. | Baseline to 8 hours. |
| Food consumption during the time in clinic (snacks) | Any snacks consumed during the day (baseline to 8-hours) at each visit will be recorded. The number of snacks consumed during each visit will be assessed as a numerical number (i.e., number of biscuits or pieces of fruit). The difference in snacks consumed at each visit will then be analysed for any differences | Baseline to 8 hours. |