Evaluation of Absorption and Metabolism of Phenolic Compounds From Mangoselect®, an Extract of Mangosteen. Comparison of Two Versions During a Randomized, Double-blinded and Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Fytexia
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Difference in urinary metabolites excretion between MNGDPF (Mangoselect dry powder form) and MNGEF (Mangoselect encapsulated form)
研究概览
简要总结
The aim of this study is to compare pharmacokinetics and bioavailability of phenolic compounds, mainly xanthones, from a mangosteen extract, either ingested in a dry powder form or in an encapsulated form. Absorption and metabolism will be determined by measuring urinary excretion of phenolic metabolites and blood metabolic profile over 72 hours by means of High Pressure Liquid Chromatography (HPLC) coupled with tandem mass spectroscopy.
The design of this study is a cross-over, double-blind and randomized trial on 10 healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent study
- •Stated willingness to comply with all the study procedures and availability for the duration of the study
- •Male and female
- •Normal BMI range (18.50-24.99)
- •In good general health as evidenced by medical history
- •Ability to take oral medication and be willing to adhere to lifestyle considerations
排除标准
- •Current use of any medication or food supplement
- •Pregnancy or lactation
- •Known allergic reaction to mangosteen
- •Metabolic disorders or any kind of disease
- •Currant smoker
结局指标
主要结局
Difference in urinary metabolites excretion between MNGDPF (Mangoselect dry powder form) and MNGEF (Mangoselect encapsulated form)
时间窗: Baseline (post-ingestion), 0-3 hours, 3-6 hours, 6-10 hours, 10-14 hours, 14-24 hours, 24-48 hours, 48-72 hours
Urine samples will be collected in baseline and up to 72h after ingestion of the supplement according to the time frame. Urinary metabolites will be identified and quantified by High Pressure Liquid Chromatography-Mass spectrometry (HPLC-MS).
次要结局
- Difference in plasma concentration of phenolic metabolites between MNGDPF and MNGEF(Baseline (post-ingestion), 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 19 hours, 24 hours, 48 hours)