Determination of the Biological Activity of Enriched Serums on Healthy Volunteers After Consumption of the Kera-Diet® Ingredient, CnC2024 - Kera-Diet®
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Determination of the influence of human serums enriched with circulating metabolites on human cell cultures
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 Kera-Diet® food supplement, to determine the influence of these sera enriched with circulating metabolites (versus naïve sera) on the behavior of human cell cultures, placed under stress conditions or not, in order to evaluate the benefit of these metabolites in maintaining cellular functions.
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
- •Main inclusion Criteria:
- •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).
- •Max 5 hours of intense sports per week.
- •Weight ≥ 60 kg.
- •BMI between 20 and 28 kg/m² (exclusive).
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, particularly to keratin or certain amino acids.
- •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.
结局指标
主要结局
Determination of the influence of human serums enriched with circulating metabolites on human cell cultures
时间窗: Determination of the absorption peak: kinetics will be determined by a blood draw at different time points (T0, T5, T10, T20, T30, T45, T60, T80, T100, T120, T140, T180, T240 minutes) over the 4 hours following the ingestion of the study product
Determination of the influence of human serums enriched with circulating metabolites (versus naïve serums) on the behavior of human cell cultures exposed or not to stress conditions in order to evaluate the benefit of these metabolites in maintaining cellular functions.
次要结局
未报告次要终点