NCT02732158已完成不适用
Feasibility of Novel Laboratory Methods for Use in Nutrition Studies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Comparison of lab values from venipuncture and DBS methods
研究概览
简要总结
This prospective, nonrandomized, feasibility study will compare laboratory measures at the beginning and end of the study period in adults consuming a nutritional study product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must agree to refrain from taking supplements other than study product.
- •Participant states willingness to follow protocol as described, including consumption of study product per protocol, performing finger stick/DBS on Day 60 and completing any forms needed throughout the study.
排除标准
- •Body Mass Index (BMI) > or equal to 35 kg/m2
- •Has planned elective surgery requiring 2 or more days of hospitalization during the entire study
- •Has stated active malignant disease
- •Has a known history of chronic renal parenchymal disease
- •Has a known history of severe liver disease/liver failure
- •Has any psychiatric disorders that would interfere with study product consumption or compliance with the study procedures
- •Known allergy or intolerance to any study product ingredient
- •Participation in another study that has not been approved as a concomitant study
结局指标
主要结局
Comparison of lab values from venipuncture and DBS methods
时间窗: Baseline
Correlation and difference in baseline levels of AN777 and carotenoids between samples collected through venipuncture and fingerstick on dried blood spot (DBS) cards.
次要结局
- Change in carotenoids(Baseline to Day 60)
- Change in AN777(Baseline to Day 60)
- Compliance of study product consumption(Baseline to Day 60)
研究者
研究点 (2)
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