跳至主要内容
临床试验/NCT02790658
NCT02790658已完成不适用

Metabolomics Approach After Acute Intake of Grumixama Juice (Eugenia Brasiliensis Lam)

University of Sao Paulo0 个研究点目标入组 15 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
主要终点
Identification of metabolites in plasma and urine samples of 15 healthy volunteers after intake of grumixama juice by GCMS.

研究概览

简要总结

Investigate the bioavailability of the main flavonoid, their colonic transformation and untargeted metabolites by an metabolomic approach following acute intake of a grumixama juice by humans.

详细描述

The grumixama is a sweet and little cherry native of the South and Southeast regions of the Atlantic Forest of Brazil rich in phenolic compounds, mainly anthocyanins and ellagitannins. The objective of this study is Investigate the bioavailability of the main flavonoid, their colonic transformation and untargeted metabolites by an metabolomic approach following acute intake of a grumixama juice by humans.

Fifteen healthy subjects consumed grumixama juice at single dose, and urine and plasma samples were collected at different time points over 24 h period. The metabolites were analyzed by LC-ESI-MSn, LC-Q-TOF plasma and urine were also analyzed using untargeted metabolomic approach for amino acids and organic acids by GCMS.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Not have medical historical of cardiovascular, gastrointestinal, hepatic, renal, thyroid and/or diabetes dysfunction
  • Not be alcohol addicts, not use vitamins and other supplements
  • Not are using any kind of medication which affect the digestion and absorption of food, not be smokers
  • Not are pregnant.

排除标准

  • Have medical historical of cardiovascular, gastrointestinal, hepatic, renal, thyroid and/or diabetes dysfunction
  • Be alcohol addicts, use vitamins and other supplements
  • Are using any kind of medication which affect the digestion and absorption of food, be smokers
  • Are pregnant.

结局指标

主要结局

Identification of metabolites in plasma and urine samples of 15 healthy volunteers after intake of grumixama juice by GCMS.

时间窗: 2 months

The samples were collected as describe in "Arms and Interventions", but for urine samples were used only the samples collected at times 0 (before the juice intake), 0-1h, 1-2h, 2-4h and at 24h after intake. The plasma samples had their proteins precipitated with cold methanol, the metabolites were extracted, concentrated and the amino acids and organic acids were derivatized to became volatile and the samples were analyzed by GCMS. For urine samples the procedures were similar. The mass fragment profile of derivatized compounds were compared to a GCMS library.

Identification of metabolites in plasma and urine samples of 15 healthy volunteers after intake of grumixama juice by LCMS

时间窗: 2 months

The blood and urine samples were collected in the times describe in "Arms and Interventions". The samples were acidified and the anthocyanins and ellagitannins metabolites were extracted by SPE column, these metabolites extracted were concentrated and analyzed by LC-ESI-MSn (for phenolic acids and anthocyanins) and LC-Q-TOF (for urolithins), the mass fragments were expressed in m/z.

次要结局

  • Pathway analysis of metabolites identified by GCMS(1 month)
  • Identification of anthocyanins in urine samples of 10 healthy volunteers by LCMS.(2 months)
  • Urinary creatinine values of 15 healthy volunteers for data normalization(15 days)
  • Multivariate data analysis of metabolites identified in plasma and urine of 15 healthy volunteers after intake of grumixama juice by GCMS(2 months)
  • Identification of urolithins in urine samples of 10 healthy volunteers by LCMS(2 months)
  • The total elimination of anthocyanins in urine of 10 healthy volunteers after intake of grumixama juice(1 month)
  • Identification of phenolic acids in plasma and urine samples of 10 healthy volunteers by LCMS(2 months)
  • Quantification of anthocyanins in urine samples of 10 healthy volunteers by HPLC(2 months)
  • Quantification of urolithins in urine samples of 10 healthy volunteers by HPLC(2 months)
  • Pharmacokinetic parameters (AUC) of phenolic acids in urine of 10 healthy volunteers after intake of grumixama juice(1 month)
  • Urine volume(1 day)
  • The total elimination of urolithins in urine of 10 healthy volunteers after intake of grumixama juice(1 month)
  • Cycle cell analysis in breast cancer cells treated with metabolites extracted from plasma and urine of 10 healthy volunteers after grumixama juice intake(2 days)
  • Quantification of phenolic acids in urine samples of 10 healthy volunteers by HPLC(2 months)
  • Pharmacokinetic parameters (AUC) of urolithins in urine of 10 healthy volunteers after intake of grumixama juice(1 month)
  • The total elimination of phenolic acids in urine of 10 healthy volunteers after intake of grumixama juice(1 month)
  • Antiproliferative activity of metabolites extracted from urine of 10 healthy volunteers after grumixama juice intake(2 days)
  • Quantification of amino acids identified by GCMS(1 month)
  • Antiproliferative activity of metabolites extracted from plasma of 10 healthy volunteers after grumixama juice intake(2 days)
  • Quantification of organic acids identified by GCMS(1 month)
  • Quantification of phenolic acids in plasma samples of 10 healthy volunteers by HPLC(2 months)
  • Pharmacokinetic parameters (AUC) of anthocyanins in urine of 10 healthy volunteers after intake of grumixama juice(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luciane de Lira Teixeira

Principal Investigator

University of Sao Paulo

相似试验

Metabolomics Approach After Acute Intake of... | 临床试验