TRPTI Metabolic and GLP-1 Pharmacodynamic Study

• TRPTI (Dietary supplement), also known as Oleoylethanolamide: Participants will receive a single capsule of 150mg TRPTI
• Placebo (Other): Participants will receive a single capsule of placebo

Primary outcomes

• Change from baseline in plasma GLP-1 concentration [Baseline to 8hrs]: 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

Secondary outcomes

• GLP-1 area under the curve (AUC) [Baseline to 8hrs]: 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
• Change from baseline at each individual time point for: GIP [Baseline to 8hrs]: Change from baseline at each individual time point for: GIP
• Change from baseline at each individual time point for: DPP-4 (dipeptidyl peptidase-4) [Baseline to 8hrs]: Change from baseline at each individual time point for: DPP-4 (dipeptidyl peptidase-4)
• Change from baseline at each individual time point for: glucose [Baseline to 8hrs]: Change from baseline at each individual time point for: glucose
• Change from baseline at each individual time point for: insulin [Baseline to 8hrs]: Change from baseline at each individual time point for: insulin
• AUC (total and blocks) for: GIP [Baseline to 8hrs]: AUC (total and blocks) for: GIP
• AUC (total and blocks) for: DPP-4 [Baseline to 8hrs]: AUC (total and blocks) for: DPP-4
• AUC (total and blocks) for: glucose [Baseline to 8hrs]: AUC (total and blocks) for: glucose
• AUC (total and blocks) for: insulin [Baseline to 8hrs]: AUC (total and blocks) for: insulin
• Tmax for GLP-1 [Baseline to 8hrs]: Tmax for GLP-1
• Tmax for DPP-4 [Baseline to 8hrs]: Tmax for DPP-4
• Tmax for glucose [Baseline to 8hrs]: Tmax for glucose
• Tmax for insulin [Baseline to 8hrs]: Tmax for insulin
• Cmax for GLP-1 [Baseline to 8hrs]: Cmax for GLP-1
• Cmax for DPP-4 [Baseline to 8hrs]: Cmax for DPP-4
• Cmax for glucose [Baseline to 8hrs]: Cmax for glucose
• Cmax for insulin [Baseline to 8hrs]: Cmax for insulin
• Tolerability including GIT tolerance [Baseline to 8 hours]: Tolerability including gastrointestinal (GIT) tolerance will be measured via a Gastronintestinal tolerance questionnaire and GIT adverse events.
• Safety via AE monitoring [Baseline to 8 hours]: Safety via AE monitoring

Other outcomes

• Exploratory: Change from baseline at each individual time point for glucagon [Baseline to 8 hours]: Exploratory: Change from baseline at each individual time point for glucagon
• Exploratory: Change from baseline at each individual time point for PYY (peptide YY) [Baseline to 8 hours]: Exploratory: Change from baseline at each individual time point for PYY (peptide YY)
• Exploratory: AUC (total and blocks) for glucagon [Baseline to 8 hours]: AUC (total and blocks) for glucagon
• Exploratory: AUC (total and blocks) for PYY [Baseline to 8 hours]: AUC (total and blocks) for PYY
• Exploratory: Tmax for glucagon [Baseline to 8 hours]: Tmax for glucagon
• Exploratory: Tmax for PYY [Baseline to 8 hours]: Tmax for PYY
• Exploratory: Cmax for glucagon [Baseline to 8 hours]: Tmax for glucagon
• Exploratory: Cmax for PYY [Baseline to 8 hours]: Tmax for PYY
• Exploratory: Visual analogue scale (VAS) for appetite [Baseline to 8hrs]: VAS for appetite
• Exploratory: Food consumption during time in clinic [Baseline to 8 hours]: Food consumption during time in clinic
• Exploratory: E/LFT [Baseline to 8 hours]: Blood sample taken for E/LFT
• Exploratory: Subgroup analysis by BMI stratum [Baseline]: Subgroup analysis by BMI stratum (BMI 25.0-29.9 vs BMI 30.0-34.9).

Sex: All, ages: 30 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Adults aged 30 years and older
* Generally healthy
* BMI 25.0-34.9 kg/m²
* Able to provide informed consent
* Agree to not participate in another clinical trial while enrolled in this trial
* Agree not to change current diet and/or exercise frequency or intensity during entire study period
* Females using a prescribed form of birth control (e.g., oral contraceptive)
* Participant's ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points
* Able to attend the clinic on all required days

Exclusion Criteria:

* Have a serious illness e.g., neurological disorders such as MS, kidney disease, liver disease or heart conditions
* History of any glucose or insulin regulation problem, including diabetes
* Have an unstable illness e.g., thyroid gland dysfunction, uncontrolled mood disorders (e.g., depression, anxiety, bipolar)
* Diagnosed with any known metabolic or endocrine dysfunctions e.g., diabetes, NAFLD, hyperinsulinaemia, hypoglycaemia
* Use of any medication or supplements that may affect any metabolic pathway associated with satiety (e.g., GLP-1, GIP, glucagon), glucose or insulin
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Significant change in diet in the past 1 month (e.g., removal of a food group or calorie restriction)
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (>21 alcoholic drinks/week)
* Pregnant or lactating women
* Allergic to any of the ingredients in active or placebo formula
* 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)
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
* Regular use within the past 4 weeks of supplements containing OEA and LipiSperse (TRPTITM)

• RV Venkatesh, Study director, Gencor Pacific