Determination of Biological Activity of Enriched Serum Among Healthy Participants After Consumption of the Food Supplement TOTUM-448
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Valbiotis
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on oxidative stress status of human hepatocytes in a hyperlipidic pro-inflammatory context.
研究概览
简要总结
Dietary intakes of saturated fatty acids remain well above nutritional recommendations for most European countries. This may progressively lead to a pro-inflammatory context and the alteration of lipid metabolism in the liver. The hypothesis of this study is that TOTUM-448 promotes the normal function of hepatocytes in a mild inflammatory context. To determine the cellular and molecular effects of TOTUM-448, circulating bioactive molecules after TOTUM-448 intake will be collected and then studied in human hepatocytes using an innovative ex vivo clinical approach developed by Clinic'n'Cell.
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:
- •Lipid profile within reference values
- •Glycemia < 100mg/dL
- •Normal hepatic function
- •Normal blood formulation
- •Normal renal function
- •BMI between 20 and 28kg/m2
- •Non smoker or occasional smoker
排除标准
- •All types of vaccination within one month
- •Alcohol intakes superior to World Health Organization recommendations
- •Ongoing pharmacological, dietary supplement and/or probiotic treatment
- •Consumption of enriched functional foods or dietary supplements within two weeks of inclusion
- •Any known disease
- •Allergy to ingredients of the study product
- •With dietary habits incompatible with the study conduct
结局指标
主要结局
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on oxidative stress status of human hepatocytes in a hyperlipidic pro-inflammatory context.
时间窗: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on pro-inflammatory cytokine expression of human hepatocytes in a hyperlipidic pro-inflammatory context.
时间窗: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on triglyceride storage of human hepatocytes in a hyperlipidic pro-inflammatory context.
时间窗: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on cholesterol storage of human hepatocytes in a hyperlipidic pro-inflammatory context.
时间窗: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on viability of human hepatocytes in a hyperlipidic pro-inflammatory context.
时间窗: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
次要结局
- Time to reach the maximum concentration in serum of detectable polyphenol metabolite concentrations by UPLC-MS/MS.(From timepoint 0 minute to timepoint 240 minutes.)