Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Gut Microbiota-derived Metabolites (Urolithins) in Overweight Subjects. Comparison Between Two Pomegranate Extracts
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 24-hour pharmacokinetics of ellagic acid in plasma
研究概览
简要总结
Pomegranate phenolics (such as the ellagitannin punicalagin and ellagic acid) are metabolized by the human gut microbiota to yield a number of metabolites called urolithins (mainly Uro-A). Both ellagic acid (EA) and urolithins can exert a number of biological activities. However, the bioavailability of ellagic acid has been reported to be very low and the existing studies are controversial so far. The investigators want to carry out a robust (cross-over, double-blind) pharmacokinetic assay in 20 healthy volunteers, using two types of pomegranate extracts (PEs). PEs with low (PE-1) and high (PE-2) punicalagin:EA ratio will be administered. The investigators will analyze blood and urine samples using UPLC-ESI-QTOF-MS/MS. The investigators will evaluate:
- The pharmacokinetics of EA.
- The effect of punicalagin:free EA ratio on the pharmacokinetics of EA and urolithins production.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-35 years.
- •Healthy status (no illness in the previous 3-months).
排除标准
- •Pregnancy/lactation.
- •Severe medical illness/chronic disease/ or gastrointestinal pathology (ulcers, irritable bowel syndrome, ulcerative colitis, Crohn disease etc.).
- •Previous gastrointestinal surgery
- •Recent use of antibiotics (within 1-month prior to the study)
- •Suspected hypersensitivity to pomegranate or any of its components
- •Consumption of nutraceuticals, botanical extracts or other vitamin supplements or taking medication.
- •Regular consumption of ellagitannin-containing foodstuffs (walnuts, pomegranate, strawberries, raspberries, oak-aged red wine) (after filling a food-frequency questionnaire).
- •Intake of ellagitannins-containing foodstuffs the week before the pharmacokinetic intervention.
结局指标
主要结局
24-hour pharmacokinetics of ellagic acid in plasma
时间窗: Outcome measures at 0.5, 1, 2, 3, 4, 5, 6, and 24 hours post-dose.
Determination of pharmacokinetic parameters (Cmax, Tmax, AUC, etc.) for ellagic acid and derived metabolites.
次要结局
- 72-h accumulation of urolithins in urine(Changes from baseline at 24, 48 and 72 hours)
研究者
Juan Carlos Espín de Gea
Full Research Professor
National Research Council, Spain