Healthy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTBroccoli consumption
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.
Sponsors
IMDEA Food
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Broccoli-derived microRNAs Detected in Plasma (RNA Sequencing) | 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) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 15 in Fasting Total Cholesterol | Baseline (Day 0) and Day 15 | Fasting serum total cholesterol measured in milligrams per deciliter (mg/dL) using standard clinical chemistry methods. |
| Change From Baseline to Day 15 in Fasting Triglycerides | Baseline (Day 0) and Day 15 | Fasting serum triglycerides measured in milligrams per deciliter (mg/dL). |
| Change From Baseline to Day 15 in Fasting Plasma Glucose | Baseline (Day 0) and Day 15 | Fasting plasma glucose measured in milligrams per deciliter (mg/dL). |
| Change From Baseline to Day 15 in Aspartate Aminotransferase (AST) | Baseline (Day 0) and Day 15 | Serum AST measured in units per liter (U/L). |
| Change From Baseline to Day 15 in Alanine Aminotransferase (ALT) | Baseline (Day 0) and Day 15 | Serum ALT measured in units per liter (U/L). |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORAlberto Davalos
IMDEA Food
Outcome results
None listed