Starting soon
Phase 4
TRPTI Metabolic and GLP-1 Pharmacodynamic Study
Condition(s) studied
Overweight , Obesity
Investigational drug(s) / intervention(s)
TRPTIPlacebo
TRPTI: Participants will receive a single capsule of 150mg TRPTI
Placebo: Participants will receive a single capsule of placebo
Study summary
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/m², aged 30 years and older).
Researchers 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.
Participants will attend two 9-hour clinic visits (crossover design, with a minimum 6-day washout between visits).
Eligibility
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)
Primary outcome measure(s)
- 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
Trial sites (1)
| Facility | City | Region | Status |
| RDC Clinical |
Fortitude Valley |
Queensland |
|
More RDC Clinical Pty Ltd trials in Australia
Other trials for the same condition