A Randomized, Double-blind, Moncentric, Cross-over Study to Collect Human Serum After Ingestion of Hydrolyzed Collagen Peptides.

Rousselot BVBA1 个研究点分布在 1 个国家目标入组 3 人开始时间: 2025年10月22日最近更新: 2025年12月4日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: Rousselot BVBA
入组人数: 3
试验地点: 1
主要终点: collagen-derived di- and tripeptides

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This randomized, double-blind, monocentric, five-way cross-over study aims to collect human serum and plasma samples at 1 and 2 hours after ingestion of hydrolyzed collagen peptides. The enriched sera will be used for ex vivo/ in vitro experiments on skin keratinocytes, fibroblasts, and other cell types to explore the beneficial effects of bioactive collagen peptides. Blood will also be analyzed for amino acid profiles and collagen-derived peptides.

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)

入排标准

年龄范围: 35 Years 至 45 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Participant is able and willing to sign the Informed Consent Form prior to screening evaluations
•Age: 35 - 45 years
•BMI: 19 - 25 kg/m2
•Non-smoker
•Participant is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry and haematology at screening

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, significant CVD events, 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
•Low haemoglobin levels < 12 g/dL
•Regular intake of drugs or supplements possibly interfering with this study within 2 weeks prior to study start or during study (stable medication since > 3 months e.g. L-Thyroxin, blood pressure medication etc. allowed)
•Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants (e.g. Marcumar), diuretics, thiazides), which in the investigator's opinion would impact participant safety
•Not willing to avoid intake of pain relievers e.g. Paracetamol or Ibuprofen 24h prior to study days
•Participants with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study
•History of hypersensitivity to fish
•HIV-infection, acute or chronic hepatitis B and C infection
•Known pregnancy, breast feeding or intention to become pregnant during the study. A pregnancy test will be conducted during screening and visits 1-
•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
•Participants considered inappropriate for the study by investigators, including participants who are unable or unwilling to show compliance with the protocol