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NCT07850466

PHASE4

TRPTI Metabolic and GLP-1 Pharmacodynamic Study

Sponsor: RDC Clinical Pty Ltd

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

30 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10

Completion Date

2027-10

Last Updated

2026-09-30

Healthy Volunteers

Yes

Conditions

Overweight , Obesity

Interventions

DIETARY_SUPPLEMENT

TRPTI

Participants will receive a single capsule of 150mg TRPTI

OTHER

Placebo

Participants will receive a single capsule of placebo

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)

Locations (1)

RDC Clinical

Fortitude Valley, Queensland, Australia