Evaluating Kinetics and Bioavailability of Aronia Melanocarpa Extract in Healthy Young and Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Aronia metabolites in blood
研究概览
简要总结
The main objective of this study is to study the bioavailability and kinetics of acute Aronia Melanocarpa supplementation in healthy young (18-35 years) and older adults (55-75 years) adults. During the test day, participants will ingest a drink consisting of Aronia Melanocarpa extract (AME). The bioavailability and kinetics of AME will be assessed via frequent blood sampling, urine collection, and faecal sampling, in which AME and metabolite profiles will be quantified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18-35 kg/m2
- •Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
- •Stable body weight (weight gain or loss < 3 kg in the past three months)
- •Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
排除标准
- •Smoking or smoking cessation < 12 months
- •Severe medical conditions, including asthma, kidney failure, auto-inflammatory diseases, rheumatoid arthritis, diabetes mellitus, cardiovascular disease, gastrointestinal disorders such as Crohn's disease, colitis
- •Use of dietary supplements or medication affecting the main outcomes of the study (e.g. affecting gut metabolism, blood pressure medication)
- •Use of an investigational product within another biomedical intervention trial within the previous month
- •Abuse of drugs
- •More than 3 alcoholic consumptions per day
- •Known pregnancy or lactation
- •Known allergy to study product
- •Difficult venepuncture
结局指标
主要结局
Aronia metabolites in blood
时间窗: time = 0 hours until t = 48 hours
Concentrations and quality of Aronia metabolites in blood analysed with LC-MS
Aronia metabolites in urine
时间窗: time = 0 hours until t = 48 hours
Concentrations and quality of Aronia metabolites in urine analysed with LC-MS
次要结局
- Aronia metabolites in feces(time = 0 hours)
- length - baseline characteristics(time = 0 hours)
- weight - baseline characteristics(time = 0 hours)
- blood pressure (systolic and diastolic) - baseline characteristics(time = 0 hours)