Bioavailability of Maqui Berry Extracts (Delphinol® / MaquiBright®) in Healthy 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
- 1
- 主要终点
- Quantification of two specific maqui berry anthocyanins: namely Delphinidin-3-O-glucoside and Cyanidin-3-O-sambubioside in a kinetics, evaluating the change between baseline and selected time points (see below).
研究概览
简要总结
The aim of the present study is to describe the bioavailability for the proprietary standardized maqui berry extracts Delphinol® and MaquiBright® enriched in anthocyanins and in particular delphinidins. The analyses are based on two selected key substances namely delphinidin-3-glucoside and cyanidin-3-sambubioside and their metabolism to phenolic acids.
The bioavailability of anthocyanins specific for Delphinol®/MaquiBright® was analyzed in plasma sample kinetics (at 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h and 8h after intake of 1000mg standardized maqui berry extract in capsules) in 12 healthy subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- •Sex: female and male
- •Age: 18- 50 years
- •BMI ≥19 or ≤30 kg/m²
- •Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology
排除标准
- •Subjects who met one or more of the following criteria are not eligible:
- •Relevant history or presence of any medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, etc.)
- •For this study clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
- •Coffee consumption >3 cups / day
- •Consumption of more than 5 portions fruits and vegetables per day
- •Blood donation within 1 month prior to study start or during study
- •Regular intake of drugs or supplements possibly interfering with this study (e.g. Vitamin C, E, OPC etc.) within 2 weeks prior to study start or during study (Vitamin D with highest dosage of 1000 I.E. per day will be allowed)
- •Vegetarians / vegans
- •Drug-, alcohol- and medication abuses
- •Known HIV-infection
- •Known acute or chronic hepatitis B and C infection
- •Relevant allergy or known hypersensitivity against compounds of the study preparations
- •Known pregnancy, breast feeding or intention to become pregnant during the study
- •Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
- •Anticipating any planned changes in lifestyle for the duration of the study
结局指标
主要结局
Quantification of two specific maqui berry anthocyanins: namely Delphinidin-3-O-glucoside and Cyanidin-3-O-sambubioside in a kinetics, evaluating the change between baseline and selected time points (see below).
时间窗: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake
Specific anthocyanins related to maqui berry extract (Delphinol® / MaquiBright®) were measured in plasma samples of healthy subjects and assessed as change to baseline. Method: LC-MS/MS (unit \[nmol/L\]).
Quantification of two specific maqui berry anthocyanin derived metabolites: namely gallic acid and protocatechuic acid in a kinetics, evaluating the change between baseline and selected time points (see below).
时间窗: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake
Specific anthocyanin derived metabolites related to maqui berry extract (Delphinol® / MaquiBright®) were measured in plasma samples of healthy subjects and assessed as change to baseline. Method: LC-MS/MS. Results will most probably be assessed as "AUC" (area under the curve).
Ferric reducing ability of plasma (FRAP) measurement in a kinetics, evaluating the change between baseline and selected time points (see below).
时间窗: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake
The FRAP assay was performed to assess the "antioxidant power" / "antioxidant capacity" of the plasma after intake of maqui berry extract (Delphinol® / MaquiBright®). Method: photometric / absorption maximum at 593 nm (unit \[µmol/l\])
次要结局
未报告次要终点