Determination of the Biological Activity of Enriched Sera From Healthy Volunteers After Consumption of Chondroitin Sulfate of Both Animal and Fermentative Origin
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cell proliferation properties of human serum enriched with circulating metabolites after MyCondro's or bovine chondroitin sulfate ingestion
研究概览
简要总结
The study evaluates the effect of chondroitin sulfate derived from fermentation (MyCondro™) and bovine chondroitin sulfate, on the health and function of the skeletal system ex vivo, including cartilage, joint capsule, and bone tissue. The primary aim of the study is to determine the influence of human sera enriched with metabolites resulting from the ingestion of the ingredients on the metabolism of human primary cells of cartilage (chondrocytes), joint capsule (synoviocytes) and bone tissue (osteoblasts). Furthermore, the absorption kinetics of MyCondro™ and Bovine CS will be described.
详细描述
The hypothesis of this study is that chondroitin sulfate promotes the maintenance and preservation of the functionality of the skeleton (cartilage, joint capsule and bone tissue) and that the effect could be different depending on the origin and the process of obtaining these chondroitins sulfate. However, the bioavailability of this type of ingredient and the mechanisms of action that could support and differentiate the benefits on the osteoarticular sphere remain to be defined. Thus, this study aims to determine the biological activity of a human serum enriched with metabolites of interest from the consumption of the ingredients MyCondro™ (chondroitin sulfate of fermentative origin) and Bovine CS (chondroitin sulfate of animal origin) on the metabolism and function of skeletal cells (cartilage, joint capsule and bone tissue).
The primary objective of the study is to determine the influence of human sera enriched with metabolites from the ingestion of the ingredients MyCondro™ and Bovine CS on the behavior of human primary cell cultures of cartilage, joint capsule and bone tissue. The secondary objective is to characterize the absorption kinetics of the ingredients MyCondro™ and Bovine CS. Furthermore, to extend the study to the metabolism of connective tissues that could be impacted, the influence of sera enriched with metabolites from the ingestion of the ingredient MyCondro™ will be explored on human primary dermal fibroblast cultures ex vivo.
The study consists of two distinct phases. The 1st phase will determine the peak absorption of each product of the study in kinetics over 5 hours, after product ingestion.
The 2nd phase will consist of a blood sample collected before the ingestion and at the peak of absorption after ingestion of each ingredient, to collect and compare two different serum fractions; naive and an enriched with metabolites and then culture the collected serum.
The single-center study will be carried out in an open-label setting, on a cohort of 10 healthy volunteers per phase and per product. The ingredient will be taken in one go for each phase. Since each volunteer is his own control, inter-individual variation is limited. This approach aims at identifying ex vivo, the biological activity of enriched sera allowing satisfactory statistical power with very few volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18-35 years old (terminals included).
- •Liver test in the reference standards.
- •Renal assessment in the reference standards.
- •NFS in the reference standards.
- •CRP in the reference standards.
- •Blood pressure compatible with the conduct of the study.
- •Non-smoker or occasional smoker (<5 cigarettes/day or < 10ml per week of electronic cigarette liquid dosed at 3 mg/ml of nicotine).
- •< to 5 hours of intense sport per week.
- •Weight≥ to 60 kg.
- •BMI between 20 and 28 kg/m² (terminals not included).
- •Subjects able and willing to comply with the protocol and provide written informed consent.
- •Subjects affiliated to social security
排除标准
- •All types of vaccination under one month.
- •Alcohol consumption above WHO standards (>3 glasses of alcohol per day for men).
- •Ongoing treatment (medication, dietary supplement or probiotic) and within 4 weeks prior to inclusion.
- •Known pathology (including seasonal).
- •Allergy to the study product (all types)
- •People with a diet that is not suitable for the conduct of the study (e.g. vegetarian, vegan or vegan diet).
- •Change in eating habits in the 4 weeks prior to inclusion.
- •Medical and/or surgical history judged by the investigator or his/her representative to be incompatible with the trial.
- •Blood donation made in the 3 months prior to the inclusion visit or intending to do so during the study.
- •Persons under guardianship, curatorship, deprivation of liberty, safeguard of justice.
- •Refusal to sign the information sheet and consent.
- •Refusal to be registered on the National Register of Volunteers who lend themselves to research involving the human person.
- •Person who is excluded from another study on the national volunteer database, or who has received more than €6000 in the year following their participation in clinical studies.
结局指标
主要结局
Cell proliferation properties of human serum enriched with circulating metabolites after MyCondro's or bovine chondroitin sulfate ingestion
时间窗: up to 5 hours after intervention ingestion
To determine the influence of human sera enriched with metabolites from the ingestion of the ingredients MyCondro™ and bovine chondroitin sulfate on the behavior of cells in the osteoarticular sphere
Cell metabolism properties of human serum enriched with circulating metabolites after MyCondro's or bovine chondroitin sulfate ingestion
时间窗: up to 5 hours after intervention ingestion
To determine the influence of human sera enriched with metabolites from the ingestion of the ingredients MyCondro™ and bovine chondroitin sulfate on the synthesis of molecules involved in cartilage metabolism by primary cells of the osteoarticular sphere
Anti-inflammatory properties of human serum enriched with circulating metabolites after MyCondro's or bovine chondroitin sulfate ingestion
时间窗: up to 5 hours after intervention ingestion
To determine the influence of human sera enriched with metabolites from the ingestion of the ingredients MyCondro™ and bovine chondroitin sulfate on the expression of inflammatory cytokines by primary cells of the osteoarticular sphere
次要结局
- Pharmacokinetics and absorption profiles(up to 5 hours after intervention ingestion)