Pharmacokinetic Analysis of Nutrient Absorption From a Novel Liposomal Multivitamin/Mineral Formulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Iron
研究概览
简要总结
This project is a randomized crossover trial examining the pharmacokinetic profiles of standard and liposomal multivitamin/mineral (MVM) formulations in healthy adults. Each participant will complete two research visits, which will be identical except for which MVM product is consumed. At each visit, participants will report to the laboratory after an overnight fast. After a baseline blood sample is collected, the MVM product will be consumed alongside a standardized breakfast. At 2-, 4-, and 6-hours post-ingestion, additional blood samples will be collected. Concentrations of representative minerals will be analyzed to determine whether differential nutrient absorption is observed with the liposomal MVM as compared to the standard MVM product. The results of this study will provide information about a novel liposomal MVM formulation and will inform future research and commercial applications of this technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18 to 65 at time of consent
- •ability to comply with study procedures
- •availability to complete study based on durations of individual visits and scheduling requirements
- •body mass of at least 110 pounds
排除标准
- •failure to meet any of the aforementioned inclusion criteria
- •presence of a disease or medical condition that could reasonably influence study outcomes or make participation inadvisable
- •use of medication that could reasonably influence study outcomes or make participation inadvisable
- •inability to abstain from medication, supplement, or substance use during the overnight fast and duration of the study visit
- •anticipated inability to provide blood samples (e.g., known difficulty providing blood samples)
- •currently pregnant or breastfeeding, based on self-report
- •allergy that would prevent safe consumption of standardized breakfast or multivitamin product
结局指标
主要结局
Iron
时间窗: The Cmax value will be determined as the highest concentration observed from four time points: immediately prior to multivitamin/mineral ingestion and 2, 4, and 6 hours after ingestion of multivitamin/mineral.
Maximal concentration (Cmax) of iron in serum
Magnesium
时间窗: The Cmax value will be determined as the highest concentration observed from four time points: immediately prior to multivitamin/mineral ingestion and 2, 4, and 6 hours after ingestion of multivitamin/mineral.
Maximal concentration (Cmax) of magnesium in serum
次要结局
未报告次要终点