Anthocyanin Bioavailability and Plasma Antioxidant Capacity in Healthy Volunteers After Acute Rice Intake
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in plasma total anthocyanin detection
研究概览
简要总结
Aims of the project
- To determine the rice anthocyanin content via high-performance liquid chromatographycoupled to mass spectrometry, HPLC-MS
- To study the oral bioavailability of anthocyanins in healthy volunteers after the intake of a serving (80 g) of black rice (Venere and Artemide varieties).
- To determine the plasma biokinetics parameters of rice anthocyanins via spectrophometric determination and high-performance liquid chromatographycoupled to mass spectrometry, HPLC-MS.
详细描述
To limit the interindividual variability, The protocol will be designed as a prospective, randomized, cross-over pharmacokinetic study on healthy volunteers. Participants will be randomly divided into three groups (black rice Venere, black rice Artemide and white rice/control) by an allocation software ( http://graphpad.com/quickcalcs/randomise1.cfm ) which will generate different random sequences of the treatment assignment.
Subjects will be deprived of anthocyanin-rich food sources 7 days before experimentation (wash-out period). Each volunteer will receive a complete list of anthocyanin-rich foods to be avoided, including berry fruits (i.e. blueberries, cranberries, raspberries, blackcurrants and elderberries), red/violet fruits/vegetables (i.e. grapes, cherries, pomegranates, red apples, plums, eggplants, tomatoes and peppers), red wine and other colored products (i.e. marmalade, jams and juices containing berries). Breakfast, lunch and dinner will be standardized 1 day before the experiment. Each group will randomly receive, during three different experimental days, one of the following treatments by different allocation sequences:
- 80g of black rice Venere (Group A)
- 80g of black rice Artemide (Group B)
- 80g of white rice (Group C)
Therefore, each subject will be involved in three experimental days. The three treatments will be separated by a 7 day wash-out period.
After an overnight fast, volunteers will consume the rice serving within 10-15 min, immediately after the first basal blood collection at 8:00 a.m. (baseline). Other blood withdrawals will be collected after 30 minutes, 1 hour, 2 hours, 3 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy status
- •Age: 18-45
- •Normal weight (BMI 18.5-24.9) who voluntarily accept to join the study, after informed consent.
排除标准
- •<18 Years;
- •Pregnancy and lactation;
- •Systemic disorders;
- •Dietary supplements intake (vitamins, antioxidants, botanicals, phytochemicals)
- •Abnormal hematological parameters;
- •Heavy smoking and alcohol drinking;
- •High-intensity physical activity.
结局指标
主要结局
Changes in plasma total anthocyanin detection
时间窗: 0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours
Total anthocyanins will be detected via spectrophometric determination; expressed as μg of catechin per mL of plasma
Changes in plasma Cyanidin-3-O-glucoside detection
时间窗: 0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours
Cyanidin-3-O-glucoside will be detected via high-performance liquid chromatographycoupled to mass spectrometry, HPLC-MS) in plasma; expressed nM (nano molar) in plasma
次要结局
- Changes in plasma antioxidant capacity ABTS(0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours)
- Changes in plasma antioxidant capacity DPPH(0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours)
研究者
Marcello Iriti
Professor
University of Milan