Detection Of Plant miRNAs After Broccoli Consumption In Human Plasma: Role Of "Cross-Kingdom" Regulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Broccoli-derived microRNAs Detected in Plasma (RNA Sequencing)
研究概览
简要总结
Nutritional clinical study to evaluate the absorption and presence of exogenous miRNAs from broccoli in plasma and peripheral blood mononuclear cells (PBMCs) and to determine their possible implication in the modulation of fecal miRNAs and gut microbiota in healthy volunteers.
详细描述
Nutritional clinical study to evaluate the absorption and presence of exogenous miRNAs from broccoli in plasma and in peripheral blood mononuclear cells (PBMCs) and determine their possible involvement in the modulation of fecal miRNAs and gut microbiota in healthy volunteers. For this purpose, two nutritional interventions will be carried out: the first will consist of an acute intake to evaluate the pharmacokinetics of exogenous miRNAs of broccoli in human plasma, and the second will be a sustained daily intake of 200g broccoli for a duration of 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women > 18 years and < 45 years
- •Adequate cultural level and understanding of the clinical study.
- •Agree to voluntarily participate in the study and give their written informed consent.
排除标准
- •Intolerance to broccoli
- •Having to follow some type of dietary restriction that prevents the consumption of broccoli.
- •Not willing to consume the food in the required quantity and/or frequency.
- •Subjects with severe disease (hepatic, renal, cardiovascular, etc.)
- •Subjects under any type of pharmacological treatment.
- •Having taken antibiotics 1 month before the start of the study (Specific for the 2-week long study).
- •Pregnancy or breastfeeding.
- •Subjects who refuse to collect stool samples or undergo the blood draws scheduled in the study.
- •Not able or willing to travel to the study site.
研究组 & 干预措施
Broccoli consumption
200g daily broccoli consumption, for 2 weeks
干预措施: Broccoli consumption (Dietary Supplement)
结局指标
主要结局
Number of Broccoli-derived microRNAs Detected in Plasma (RNA Sequencing)
时间窗: Baseline (pre-consumption), 1 Hour, 3 Hours, and 6 Hours Post-consumption
Plasma samples will be analyzed by small RNA sequencing (RNA-seq). The outcome is the count of broccoli-derived microRNA species detected per sample using pre-specified detection criteria (e.g., minimum read threshold and alignment to reference sequences).
Change From Baseline to Day 15 in Plasma Level of Selected Broccoli-derived microRNAs (qRT-PCR)
时间窗: Baseline (Day 0, pre-consumption) and Day 15
Candidate broccoli-derived microRNAs (selected based on RNA-seq results using pre-specified selection rules) will be quantified in plasma by qRT-PCR. The outcome is fold change from baseline to Day 15, calculated as 2\^-ΔΔCt (unitless).
Change From Baseline to Day 15 in Gut Microbiota Alpha Diversity (Shannon Index)
时间窗: Baseline (Day -1) and Day 15
Stool samples will undergo high-throughput sequencing for microbiota profiling. Alpha diversity will be summarized using the Shannon diversity index (unitless).
Number of Broccoli-derived microRNAs Detected in Stool (RNA Sequencing)
时间窗: Baseline (Day -1) and Day 15
Stool RNA will be profiled by small RNA sequencing. The outcome is the count of broccoli-derived microRNA species detected per sample using pre-specified detection criteria.
次要结局
- Change From Baseline to Day 15 in Fasting Plasma Glucose(Baseline (Day 0) and Day 15)
- Change From Baseline to Day 15 in Fasting Total Cholesterol(Baseline (Day 0) and Day 15)
- Change From Baseline to Day 15 in Fasting Triglycerides(Baseline (Day 0) and Day 15)
- Change From Baseline to Day 15 in Aspartate Aminotransferase (AST)(Baseline (Day 0) and Day 15)
- Change From Baseline to Day 15 in Alanine Aminotransferase (ALT)(Baseline (Day 0) and Day 15)
研究者
Alberto Davalos Herrera
Senior Investigator
IMDEA Food