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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
20
Clinical-nutritional intervention involving two studies: 1) study to evaluate the pharmacokinetics of exogenous miRNAs in human plasma after acute intake of 200g of broccoli, and 2) sustained study where volunteers intake 200g of broccoli daily, for 2 weeks.
Imdea-Food
Madrid, Madrid, Spain
Number of Broccoli-derived microRNAs Detected in Plasma (RNA Sequencing)
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).
Time frame: Baseline (pre-consumption), 1 Hour, 3 Hours, and 6 Hours Post-consumption
Change From Baseline to Day 15 in Plasma Level of Selected Broccoli-derived microRNAs (qRT-PCR)
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).
Time frame: Baseline (Day 0, pre-consumption) and Day 15
Change From Baseline to Day 15 in Gut Microbiota Alpha Diversity (Shannon Index)
Stool samples will undergo high-throughput sequencing for microbiota profiling. Alpha diversity will be summarized using the Shannon diversity index (unitless).
Time frame: Baseline (Day -1) and Day 15
Number of Broccoli-derived microRNAs Detected in Stool (RNA Sequencing)
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.
Time frame: Baseline (Day -1) and Day 15
Change From Baseline to Day 15 in Fasting Total Cholesterol
Fasting serum total cholesterol measured in milligrams per deciliter (mg/dL) using standard clinical chemistry methods.
Time frame: Baseline (Day 0) and Day 15
Change From Baseline to Day 15 in Fasting Triglycerides
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Fasting serum triglycerides measured in milligrams per deciliter (mg/dL).
Time frame: Baseline (Day 0) and Day 15
Change From Baseline to Day 15 in Fasting Plasma Glucose
Fasting plasma glucose measured in milligrams per deciliter (mg/dL).
Time frame: Baseline (Day 0) and Day 15
Change From Baseline to Day 15 in Aspartate Aminotransferase (AST)
Serum AST measured in units per liter (U/L).
Time frame: Baseline (Day 0) and Day 15
Change From Baseline to Day 15 in Alanine Aminotransferase (ALT)
Serum ALT measured in units per liter (U/L).
Time frame: Baseline (Day 0) and Day 15