Evaluation of Enhanced Absorption of a Micellar Curcumin Formulation (curQ+) or a Liposomal Curcumin Formulation Versus 95% Curcumin Extract in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Absorption of curcumin as measured in serum via Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS)
研究概览
简要总结
This study is intended to evaluate how significantly a proprietary curcumin formulation (curQ+® or liposomal curcumin) results in greater GI absorption compared to 95% curcumin extract over a 6-hour time period following a single oral dose in healthy men & women.
详细描述
This study is intended to evaluate how significantly a proprietary curcumin formulation (curQ+® or liposomal curcumin) results in greater GI absorption compared to 95% curcumin extract over a 6-hour time period following a single oral dose in healthy men & women. Absorption enhancement will be based upon producing the greatest plasma curcumin concentration (AUC). Secondarily, this study is intended to evaluate the safety and tolerability of the curQ+® & liposomal curcumin formulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Open label - all are aware of intervention assignment
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female subjects must be 18-75 years of age at the time of Screening.
- •Subjects must be willing to refrain from consuming the spice turmeric or any dietary supplements containing turmeric or curcumin (except for the study products) throughout the entire study and for 14 days prior to screening.
- •Subjects must be available for and willing to attend all evaluation visits.
- •Subjects must be able and willing to give informed consent.
- •Subjects participating in prior studies evaluating curQ+® or curcumin can participate in the present study so long as they are not currently taking a curcumin-containing supplement (including turmeric) and have not done so for 14 days prior to screening.
排除标准
- •Subject is currently receiving therapy with remission-inducing drugs (i.e. methotrexate, TNF biologics, etc.), immunosuppressive drugs (i.e. corticosteroids, transplantation medications, etc.).
- •Subjects must not have taken turmeric- or curcumin-containing dietary supplements within 14 days prior to screening evaluation.
- •Subject has been diagnosed with any clinically significant confounding metabolic disease or condition that would interfere with the study evaluation, as judged by the clinical investigator (slow or fast metabolism resulting from hypo- or hyper-thyroidism, Cushing's Syndrome, Diabetes (except for fully resolved gestational diabetes), etc.) or any conditions that would affect absorption in the GI tract (i.e. inflammatory bowel disease, celiac disease, Behçet's Syndrome, systemic sclerosis, etc.).
- •Subject has known allergy to any of the investigational products, including but not limited to turmeric, curcumin, coconut or coconut oil, and sunflower oil. If any subject becomes sensitive during the study, they will immediately be excluded from continuing in the study.
- •Subject's body weight is greater than 300 pounds (136.1 kg) at the time of Screening.
- •Subject is involved in any other research study involving an investigational product (drug, device or biologic) or a new application of an approved product, within 30 days of the first baseline evaluation.
- •Pregnant and/or breastfeeding women, or women who intend to become pregnant during the course of the study.
研究组 & 干预措施
95% curcumin extract powder
1,035 mg of 95% curcumin extract (~1,000 mg of curcuminoids) in three #0 vegetarian capsules as a single oral dose
干预措施: 95% curcumin extract powder (Dietary Supplement)
curQ+ curcumin formulation
2,010 mg of curQ+® containing a total of 350 mg of curcuminoids in six #0 vegetarian capsules as a single oral dose
干预措施: curQ+ curcumin formulation (Dietary Supplement)
Liposomal curcumin formulation
15.4 g of liposomal curcumin containing a total of ~940 mg of curcuminoids in a 15 mL syringe as a single oral dose
干预措施: liposomal curcumin formulation (Dietary Supplement)
结局指标
主要结局
Absorption of curcumin as measured in serum via Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS)
时间窗: 6 hours
The difference between the absorption of curcumin from the formulations curQ+ or liposomal curcumin versus 95% curcumin powder as measured in serum via Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS)
次要结局
未报告次要终点