A Double-blind, Randomised, Placebo-controlled Parallel Study to Assess the Effectiveness of TRPTI (Oleoylethanolamide) Compared to Placebo on Gut Microbiome and Plasma Biomarker Changes in Healthy Adults
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Imidazole Propionate (ImP)
研究概览
简要总结
The goal of this clinical trial is to assess whether TRPTI (oleoylethanolamide) can reduce plasma imidazole propionate levels and improve insulin sensitivity and metabolic health in healthy adults aged 18 years and above with BMI 18.5-29.9 kg/m². The main question it aims to answer is does TRPTI reduce plasma imidazole propionate (a gut microbiota-derived metabolite linked to insulin resistance)?
Researchers will compare TRPTI 300 mg to placebo in a parallel design to see if TRPTI reduces imidazole propionate levels and improves metabolic health markers compared to placebo.
Participants will:
- Take 2 capsules of their assigned study product daily for 8 consecutive weeks
- Attend 3 clinic visits (at baseline, week 4 and week 8)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 24.9 - 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
- •Stable diet and lifestyle for at least 4 weeks prior
- •Females using a prescribed form of birth control (e.g. oral contraceptive)
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 gastrointestinal disorders (IBD, IBS, celiac disease, etc.)
- •Use of antibiotics within 8 weeks prior to study entry
- •Regular use of medications that significantly affect gut microbiome (PPIs, laxatives, antacids)
- •Use of probiotics, prebiotics, or symbiotic within 4 weeks prior to study entry
- •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 4 weeksb prior to study entry
- •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
- •History of infection in the month prior to the study
研究组 & 干预措施
TRPTI 150 mg
Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 150mg.
干预措施: TRPTI 150mg (Dietary Supplement)
TRPTI 300mg
Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg.
干预措施: TRPTI 300mg (Dietary Supplement)
Placebo
Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg.
干预措施: Placebo (Other)
结局指标
主要结局
Imidazole Propionate (ImP)
时间窗: Baseline to week 4
Plasma ImP concentration: Primary metabolite produced by histidine-metabolizing gut bacteria, strongly associated with insulin resistance and type 2 diabetes risk Change from baseline: Reduction in ImP levels indicating improved metabolic health
次要结局
- Gut Microbiome Composition(Baseline to week 4)
- Histidine Metabolic Pathway - Histidine(Baseline to week 4)
- Histidine Metabolic Pathway - Histamine(Baseline to week 4)
- Histidine Metabolic Pathway - Urocanic acid(Baseline to week 4)
- Insulin Sensitivity and Metabolic Health: HOMA-IR(Baseline to week 4)
- Insulin Sensitivity and Metabolic Health: HOMA2(Baseline to week 4)
- Safety and Tolerability - Adverse events(Baseline to week 4)
- Safety and Tolerability - Blood pressure(Baseline to week 4)
- Safety and Tolerability - Heart Rate(Baseline to week 4)
- Safety and Tolerability - E/LFT (electrolytes)(Baseline to week 4)
- Safety and Tolerability - E/LFT (Liver Function test)(Baseline to week 4)