Impact of the Source and Polyphenol-containing Food Matrices on the Bioavailability of Peptan® (Collagen Peptides) in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Area Under the Curve (AUC(0-6h)) for hydroxyproline after single dose of the different collagen peptides.
研究概览
简要总结
The aim of this study is the comparison of the oral bioavailability of hydroxyproline, a key marker for collagen peptide intake, after ingestion of collagen peptides from different sources, sizes and together with different food matrices, either containing high or low levels of polyphenols.
详细描述
The absorption (blood) of collagen peptides from bovine, fish and porcine source in different sizes and administered together with foods of different polyphenol content will be assessed. Pharmacokinetic parameters (AUC0-6h, Cmax and Tmax) after oral single dose administration will be determined to estimate the impact of different sources, different peptide sized any food matrix.
The following objectives will be evaluated exploratory by comparison of pharmacokinetic parameters from the concentration time curve of hydroxyproline, a key marker of collagen type I, between:
- different sources of collagen peptides (bovine, fish, porcine)
- different sizes of collagen peptides from cattle
- food matrices impact on uptake of bovine collagen peptides (dissolved in water vs. food matrix 1 vs. food matrix 2).
Additionally, concentration time curves of further amino acids will be assessed descriptively.
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 study
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 (50 % of each gender)
- •Age: 18-50 years
- •BMI ≥19 and ≤28 kg/m²
- •Nonsmoker
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.)
- •Significant changes in lifestyle or medication (within last 3 mo.) or surgical intervention or surgical procedure such as bariatric surgery
- •Application of corticoids (intravenously, orally or intraarticularly) and other immune-suppressing drug (within last 2 weeks)
- •Blood donation within 1 month prior to study start or during study
- •Regular intake of drugs or supplements possibly interfering with this study (Glucosamine, chondroitin sulfate, hyaluronic acid, omega-3, folic acid, curcumin/turmeric, Boswellia serrata, collagen, Vitamin D) within 2 weeks prior to study start or during study
- •Intake of anticoagulants like Heparin, Marcumar etc.
- •Coffee consumption >3 cups / day
- •History of hypersensitivity to fish
结局指标
主要结局
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
Time to reach the maximum concentration of hydroxyproline (Tmax)
时间窗: pre dose and up to 6 hours post dose
Pharmakokinetic variable
次要结局
- Concentration-time of essential and not essential amino acids(pre dose and up to 6 hours post dose)