A Randomised, Double-blind, Placebo-controlled Crossover Study to Assess the Effect of TRPTI (Oleoylethanolamide) on Glucose Tolerance in Healthy Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Glucose Tolerance - AUC
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years and above
- •Generally healthy
- •BMI 18.5-29.9 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)
- •Able to attend the clinic on all required days.
排除标准
- •Unstable or serious illness (e.g. Serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, thyroid gland dysfunction)
- •Known diabetes (Type I or II), or impaired glucose tolerance
- •Fasting glucose ≥5.9 mmol/L or known random glucose ≥11.1 mmol/L
- •Use of medications that affect glucose metabolism (e.g., corticosteroids, beta-blockers, diuretics).
- •Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years
- •Active smokers, nicotine use, alcohol or drug (prescription or illegal substances) abuse
- •Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- •Allergic to any of the ingredients in the active or placebo formula
- •Consistently (3 or more days per week) taken OEA within the past 4 weeks
- •Known pregnant or lactating woman
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- •Participants who have participated in any other non-RDC related clinical study during the past 1 month
- •Recent infection or trauma in the month prior to the study or on the days of the clinic visits
研究组 & 干预措施
TRPTI 150mg
Single dose of 150mg TRPTI will be administered orally.
干预措施: TRPTI 150mg (Dietary Supplement)
TRPTI 300mg
Single dose of 300mg TRPTI will be administered orally.
干预措施: TRPTI 300mg (Dietary Supplement)
Placebo
Single dose of placebo will be administered orally.
干预措施: Placebo (Other)
结局指标
主要结局
Glucose Tolerance - AUC
时间窗: 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
Glucose - Peak glucose response
时间窗: 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.
Glucose Tolerance - Time to Peak Glucose
时间窗: 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.
次要结局
- Insulin Response - AUC(0 to 120 minutes)
- Insulin Response - Peak insulin response(0 to 120 minutes)
- Insulin Response - HOMA-IR(0 minutes)