Intervention Effect of Tea Polyphenols (TP) and Water-Soluble Antioxidant Of Bamboo Leaves (AOB-w) on Short- and Long-term Internal Exposure of Acrylamide in Chinese Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 主要终点
- Change of two hemoglobin adducts of acrylamide
研究概览
简要总结
A double-blind randomized controlled trial (RCT) was conducted in current human study. This study aims to investigate the intervention effect of AOB-w on the short-term exposure and toxicokinetics of acrylamide, a dietary hazardous substance generated during heat processing, in Chinese adolescents.
详细描述
In the morning of test day, participants were served with a meal of potato chips, corresponding to a single oral dose of 12.6 μg/kg b.w. exposure to acrylamide, and an edible capsule, which contains 350 mg AOB-w or the placebo with the same dose. Urine were collected within 48 hours thereafter. The diet was rigorously controlled within 24 hours prior to study till entire study finished. Four mercapturic acid metabolites have been investigated as urinary biomarkers for short-term internal exposure of acrylamide in human
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has no smoking or drinking hobby
排除标准
- •Having any drugs within 7days
- •Smoking or drinking
- •Pregnant, trying to become pregnant or breast feeding
- •Allergic frying foods
结局指标
主要结局
Change of two hemoglobin adducts of acrylamide
时间窗: baseline, 3 and 10 days
Blood samples were collected in 0, 3, 10days after the intake of potato chips meals. Two hemoglobin adducts (AAVal and GAVal) of acrylamide were detected by UHPLC-MS/MS.
Change of four urinary biomarkers of acrylamide
时间窗: up to 48 hours
Urine was collected prior to the potato chips meal and 48 hours thereafter, up to 10 urine samples for each participants. Urinary biomarkers of acrylamide were detected by UHPLC-MS/MS.
次要结局
- Time to Peak Concentration (tmax) of Acrylamide Urinary Biomarkers(48 hours)
- Area under the concentration versus time curve (AUC) Of acrylamide urinary biomarkers(baseline, 2, 4, 6, 8, 10, 14, 24, 36 and 48 hours)
- Maximum Concentration (Cmax) of Acrylamide Urinary Biomarkers(48 hours)
研究者
Yu Zhang
Associate professor
Zhejiang University