Scavenging of Endogenous Reactive Carbonyl Species by Apple Polyphenols in Healthy Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in plasma levels of RCS adducts of apple polyphenols over 24 hours after one single dose of apple consumption
研究概览
简要总结
This is an interventional study to investigate formation and pharmacokinetics of reactive carbonyl species adducts of apple polyphenols in human after a single dose of apple consumption.
详细描述
A crossover design was used. Twelve healthy volunteers were recruited and asked to avoid the consumption of any apple products starting 1 week before intervention and continuing throughout the entire study for a total of 3 weeks.
On week 2, each of six participants received 600 g apple blends (seeds removal) in a single dose, and afterwards, urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h were collected. Meanwhile, other six participants received breakfast (without any apple products) only, and urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h were collected.
On the contrary, on week 3, six participants who received apple blends on week 2 received breakfast only, and six participants who were used as control on week 2 received apple blends. And urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h for both groups were collected.
Samples will be analyzed by LC-MS/MS. Pharmacokinetics of conjugates will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 17 and 30
- •Have blood and urine biochemical markers in normal range
- •Have no known allergy to apples
- •Be not taking antibiotics for six months
- •Be not currently taking medication
- •Be nonsmoking
- •Have no alcoholic intoxication
- •Have no extensive exposure to industrial wastes
- •Be not frequent charred meat consumption
排除标准
- •Individuals with gout
- •Individuals with heart diseases
- •Individuals with peripheral vascular diseases
- •Individuals with degenerative kidney
- •Individuals with degenerative liver
- •Cancer patients
- •Patients with diabetes
- •Individuals with GI disorders
- •Individuals with endocrine disorders
研究组 & 干预措施
Apple consumption
Each subject took apple blends 600 g (made from two apples with seed removal) in a single dose, and samples (urine and blood and feces) at different timepoints were collected following administration of apple blends.
干预措施: Apple consumption (Dietary Supplement)
Control group
Each subject took breakfast without any apple-related products in a single dose, and samples (urine and blood and feces) at different timepoints were collected following breakfast.
干预措施: Control group (Dietary Supplement)
结局指标
主要结局
Change in plasma levels of RCS adducts of apple polyphenols over 24 hours after one single dose of apple consumption
时间窗: 0, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose
Liquid chromatography-tandem mass spectrometry will be used to assess RCS adducts of apple polyphenols in plasma
Change in levels of RCS adducts of apple polyphenols in feces over 48 hours after one single dose of apple consumption
时间窗: 0, 24, 48 hours post-dose
Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of apple polyphenols in fecal samples
Change in urinary levels of reactive carbonyl species (RCS) adducts of apple polyphenols over 24 hours after one single dose of apple consumption
时间窗: 0-2, 2-4, 4-6, 6-9, 9-12, 12-24 hours post-dose
Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of apple polyphenols in urine
次要结局
- Change in urinary levels of RCS over 24 hours after one single dose of apple consumption(0-2, 2-4, 4-6, 6-9, 9-12, 12-24 hours post-dose)
- Change in plasma levels of RCS over 24 hours after one single dose of apple consumption(0, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose)
研究者
Shengmin Sang
Principal Investigator
North Carolina Agriculture & Technical State University