Investigation of the Bioavailability of Marine Based Collagen Peptides in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Time to reach the maximum concentration of hydroxyproline (Tmax) for hydroxyproline after single dose of the different collagen peptides.
研究概览
简要总结
The aim of this study is to evaluate the relative bioavailability of Peptan® Type I collagen peptides from different marine origin (different fish sources, production process and molecular weight) in healthy human subjects.
详细描述
The aim of this study is to evaluate the relative bioavailability of different Peptan® Type I collagen peptides in healthy human subjects. The pharmacokinetic parameters AUC0-6h, Cmax and Tmax will be determined from the concentration-time curves of characteristic collagen markers (e.g. hydroxyproline, proline, glycine, di- and tripeptides together with further amino acids) after oral single dose administration.
The following objectives will be evaluated by comparison of pharmacokinetic parameters between the products:
- The impact of different production processes
- The impact of size of collagen peptides
- The impact of different fish sources
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double-blind
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
- •Age: 18 - 50 years
- •Healthy men and women
- •BMI: 19 - 28 kg/m2
- •Non-smoker
排除标准
- •Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, heavy depression, diabetes, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.)
- •A significant CVD event within last 3 mo. incl. myocardial infarction, stroke, congestive heart failure
- •Significant changes in lifestyle or medication (within last 3 mo.) or surgical intervention or surgical procedure such as bariatric surgery
- •For this study clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
- •Blood donation within 1 month prior to study start or during study
- •"Extreme dietary regimes": vegan lifestyle, weight loss diet with <1200 kcal/day for women and <1800 kcal for men
- •Intake of anticoagulants like Heparin, Marcumar etc.
- •Regular intake of drugs or supplements possibly interfering with this study within 2 weeks prior to study start or during study
- •History of hypersensitivity to fish
结局指标
主要结局
Time to reach the maximum concentration of hydroxyproline (Tmax) for hydroxyproline after single dose of the different collagen peptides.
时间窗: pre dose and up to 6 hours post dose
Pharmakokinetic variable
Area Under the Curve (AUC(0-6h)) for hydroxyproline after single dose of the different collagen peptides.
时间窗: pre dose and up to 6 hours post dose
Pharmakokinetic variable
Peak plasma concentration after administration (Cmax) for hydroxyproline after single dose of the different collagen peptides.
时间窗: pre dose and up to 6 hours post dose
Pharmakokinetic variable
次要结局
- Area Under the Curve (AUC(0-6h)) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides(pre dose and up to 6 hours post dose)
- Peak plasma concentration after administration (Cmax) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides(pre dose and up to 6 hours post dose)
- Time to reach the maximum concentration (Tmax) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides(pre dose and up to 6 hours post dose)