Patterns of Plasma Vitamins and Minerals Following Intake of a Multivitamin/ Mineral Formula Produced by Two Different Manufacturing Processes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Assess the serum or plasma levels of five vitamins and four minerals
研究概览
简要总结
The objective of this project is to evaluate the postprandial serum and plasma vitamin and mineral levels in healthy adult men and women between 18 and 32 years of age, following a single intake of a multivitamin and mineral supplement processed in two different ways.
详细描述
Serum or plasma levels of five vitamins and four minerals will be measured at baseline, and 1, 2, 4, and 6 hours after the intake of a multivitamin/mineral supplement processed by two different methods. The two methods involve using either conventional isolated vitamins and minerals blended together to provide approximately 100% of the Daily Value, or using the same amount of vitamins and minerals that have first been processing into liposomal forms before blending.
Participants are required to come for two study visits which are 5 to 7 days apart. Health screening will also be done at Study Visit 1. The order of supplement assignment will be randomized, performed in a double-blind manner.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 32 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females 18-32 years of age
- •BMI 18.5-32 kg/m2
- •Free from disease
- •Normal blood levels in the comprehensive metabolic panel, or values slightly out of range as approved by the study physician
- •Normal blood pressure (individuals whose average blood pressure is greater than 140/90 will be excluded from the study)
- •Suitable vein structure and access for successful placement of an indwelling catheter, as determined by our nurse phlebotomist
排除标准
- •Alcohol consumption > 3 drinks/week (i.e., 1 bottle of beer, 1 glass of wine, and 1 shot of hard liquor)
- •Vaping or using cannabis in any form
- •Using multivitamin/mineral supplements in the past two months
- •Currently taking supplements including botanical supplements, probiotics or fiber
- •Fruit consumption ≥ 2 cups/day
- •Vegetable consumption ≥ 3 cups/day
- •Coffee/tea ≥ 3 cups/day
- •Chronic/routine high-intensity exercise
- •Any chronic health conditions
- •Self-reported malabsorption
- •Currently taking prescription drugs
- •Indications of substance or alcohol abuse within the last 3 years
- •Unable to consent
结局指标
主要结局
Assess the serum or plasma levels of five vitamins and four minerals
时间窗: 6 hours
Total area-under-the-curve of serum Vitamin A
次要结局
- Assess the serum or plasma levels of five vitamins and four minerals(6 hours)