RDC Clinical
Brisbane, Queensland, 4006, Australia
NCT Number: NCT07412730
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:
* Does TRPTI improve glucose tolerance as measured by glucose area under the curve (AUC) from 0-120 minutes following a glucose load? * Does TRPTI reduce peak glucose response and alter the time to peak glucose concentration? * Are there dose-dependent effects between 150 mg and 300 mg doses of TRPTI?
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 2
Brisbane, Queensland, 4006, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single dose of 150mg TRPTI will be orally administered.
Other names: Oleoylethanolamide
Single dose of 300mg TRPTI will be orally administered.
Other names: Oleoylethanolamide
Single dose of placebo will be orally administered.
Other names: microcrystalline cellulose
Time frame: 0 to 120mins
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
Time frame: 0 to 120minutes
Change from baseline to the end of the study period in Peak glucose response - Maximum glucose concentration achieved during the test period.
Time frame: 0 to 120 minutes
Change from baseline to the end of the study period in Time to peak glucose - Time point at which maximum glucose concentration occurs.
Time frame: 0 to 120 minutes
Insulin AUC (0-120 min): Area under the curve for insulin concentration from 0-120 minutes post-glucose load
Time frame: 0 to 120 minutes
Peak insulin response: Maximum insulin concentration achieved during the test period
Time frame: 0 minutes
HOMA-IR: Homeostatic Model Assessment of Insulin Resistance calculated from fasting glucose and insulin.
Time frame: Baseline to 3 hours
Adverse events: Any untoward medical occurrences during the study period
Time frame: Baseline to 3 hours
Vital signs: Blood pressure at the start and end of each visit
Time frame: Baseline to 3 hours
Vital signs: Heart rate at the start and end of each visit
Time frame: Baseline to 3 hours
GIT tolerance: Gastrointestinal Tolerance questionnaire assessing nausea, bloating, discomfort etc.
Time frame: Baseline to week 3
Weight at each visit
Time frame: Baseline to week 3
BMI at each visit
RDC Clinical Pty Ltd
Industry
A Randomised, Double-blind, Placebo-controlled Crossover Study to Assess the Effect of TRPTI (Oleoylethanolamide) on Glucose Tolerance in Healthy Adults
Acronym: OEAGTT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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