NCT06840080已完成4 期
Short-term Effect of Oleoylethanolamide (OEA) and LipiSperse Supplementation on Metabolic Pathways in Otherwise Healthy Participants - a Single Blind, Cross-over Study
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in serum/plasma GLP-1 AUC
研究概览
简要总结
A placebo controlled, single blind, cross-over study evaluating the short-term effect of oleoylethanolamide (OEA) with LipiSperse supplementation on metabolic pathways in healthy participants.
详细描述
This study aims to compare the metabolic effects of two different doses of OEA with LipiSperse to a placebo in healthy participants over an 8-hour period. There are three trial arms in this study. Each participant will complete all 3 arms of the study, for a 3-way cross-over.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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, hyperinsulinemia, 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/or LipiSperse
研究组 & 干预措施
Placebo
Placebo Comparator
Single dose of 2 capsules will be administered that appear identical to active arms.
干预措施: Placebo (Other)
125mg OEA with LipiSperse
Experimental
Single dose of 2 capsules will be administered. 1 capsule will contain 125mg OEA and 13.9mg of LipiSperse and 1 capsule will be a placebo.
干预措施: 125mg OEA with LipiSperse (Dietary Supplement)
250mg OEA with LipiSperse
Experimental
Single dose of 2 capsules will be administered. Each capsule will contain 125mg OEA and 13.9mg of LipiSperse.
干预措施: 250mg OEA with LipiSperse (Dietary Supplement)
结局指标
主要结局
Changes in serum/plasma GLP-1 AUC
时间窗: Baseline and 8 hours
Change from baseline to the end of the study period in serum/plasma GLP-1 AUC for each arm of treatment.
次要结局
- Cmax of glucose(Baseline to 8 hours)
- Cmax of insulin(Baseline to 8 hours)
- Changes in serum/plasma GIP AUC(Baseline and 8 hours)
- Changes in serum/plasma DPP-4 AUC(Baseline and 8 hours)
- Changes in serum/plasma glucagon AUC(Baseline and 8 hours)
- Changes in serum/plasma glucose AUC(Baseline and 8 hours)
- Changes in serum/plasma insulin AUC(Baseline and 8 hours)
- Tmax of GLP-1(Baseline to 8 hours)
- Tmax of GIP(Baseline to 8 hours)
- Tmax of DPP-4(Baseline to 8 hours)
- Tmax of glucagon(Baseline to 8 hours)
- Tmax of glucose(Baseline to 8 hours)
- Tmax of insulin(Baseline to 8 hours)
- Cmax of GLP-1(Baseline to 8 hours)
- Cmax of GIP(Baseline to 8 hours)
- Cmax of DPP-4(Baseline to 8 hours)
- Cmax of glucagon(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GLP-1)(Baseline to 8 hours)
- Individual absorption data for each subject(Baseline to 8 hours)
- Tolerability including GIT tolerance(Baseline to 8 hours)
- Safety via AE monitoring(Baseline to 8hours post dose)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GIP)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in DPP-4)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucagon)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucose)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in insulin)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GLP-1)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GIP)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of DPP-4)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucagon)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucose)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of insulin)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GLP-1)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GIP)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of DPP-4)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucagon)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucose)(Baseline to 8 hours)
- Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of insulin)(Baseline to 8 hours)
- VAS for appetite(Baseline to 4 hours)
- Food consumption during the time in clinic (Lunch)(Baseline to 8 hours.)
- Food consumption during the time in clinic (Breakfast)(Baseline to 8 hours.)
- Food consumption during the time in clinic (snacks)(Baseline to 8 hours.)
研究者
研究点 (1)
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