Determination of Biological Activity of Human-enriched Serum Following Chondractiv™ Plus Ingredient Ingestion : Result From an Exploratory Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Biological activity of human-enriched serum following Chondractiv™ Plus ingredient ingestion
研究概览
简要总结
The main objective of this study is, after collecting serum enriched with metabolites of interest resulting from the ingestion of the Chondractiv™ Plus food supplement (an hydrolyzed chicken collagen), to determine the influence of these sera enriched with circulating metabolites on the behavior of human joint cartilage cells placed in culture.
详细描述
The clinical study will be conducted in two phases.
- The first phase will aim at characterizing the metabolites present in human serum after consumption of the Chondractiv™ ingredient and at determining the overall absorption peak of the tested ingredient.
- The second phase will involve collecting sera enriched with metabolites at the absorption peak, following the ingestion of the ingredient. Subsequently, the final objective will be to characterize the influence of these sera enriched with metabolites of interest on the behavior of human joint cartilage cell cultures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Liver function tests within reference norms.
- •Kidney function tests within reference norms.
- •Complete blood count (CBC) within reference norms.
- •C-reactive protein (CRP) within reference norms.
- •Blood pressure compatible with study requirements.
- •Non-smoker or occasional smoker (max 5 cigarettes/day or max 10 ml per week of e-liquid with a nicotine concentration of 3 mg/ml).
- •Maximum 5 hours of intense sports per week.
- •Weight ≥ 60 kg.
- •Body Mass Index (BMI) between 20 and 28 kg/m² (exclusive).
- •Subjects who are able and willing to comply with the protocol and give their informed written consent.
- •Subjects affiliated with the social security.
排除标准
- •Any type of vaccination within the past month.
- •Alcohol consumption exceeding WHO standards (Sup. 3 drinks per day for men).
- •Ongoing treatment (medication, dietary supplement, or probiotic) and within the four weeks prior to inclusion.
- •Known pathology (including seasonal).
- •Allergy to the study product
- •Individuals following a diet unsuitable for the study (e.g., vegetarian, vegan, or plant-based diets).
- •Change in eating habits within the 4 weeks prior to inclusion.
- •Medical and/or surgical history deemed incompatible with the trial by the investigator or their representative.
- •Persons under guardianship, curatorship, deprived of freedoms, safeguarding justice.
- •Refusal to sign the information sheet and consent
研究组 & 干预措施
Chondractiv™ Plus
Phase 1: One dose of 1,5g or 4,5g or 15g
Phase 2: One dose of 15g
干预措施: Chondractiv™ Plus (Hydrolyzed chicken cartilage) (Dietary Supplement)
结局指标
主要结局
Biological activity of human-enriched serum following Chondractiv™ Plus ingredient ingestion
时间窗: T0 and Tmax (within 180 minutes after Chondractiv™ Plus ingredient ingestion, time determined during phase 1 described in secondary outcome)
The main objective of this study is to determine the influence of human serum enriched with metabolites from ingestion of Chondractiv™ Plus on the behavior of human primary chondrocyte cultures (phase 2).
次要结局
- Concentration of circulating amino-acids including hydroxyproline in blood stream. The aim is to characterize the absorption kinetics profile of Chondractiv™ Plus according to the dose ingested (phase 1).(From blood draw at different time points (T0, T30, T60, T90, T120, T180 minutes) over the 3 hours following the ingestion of the Chondractiv™ Plus)
- Proteomic(From blood draw at different time points (T0, T30, T60, T90, T120, T180 minutes) over the 3 hours following the ingestion of the Chondractiv™ Plus)