Plant miRNAs In Human Plasma After Broccoli Consumption

Detection Of Plant miRNAs After Broccoli Consumption In Human Plasma: Role Of "Cross-Kingdom" Regulation

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Broccoli consumption

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28049
      • Imdea-Food

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Broccoli consumption; 200g daily broccoli consumption, for 2 weeks	Dietary supplement: Broccoli 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	Baseline (Day -1) and Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 0) and Day 15
Change From Baseline to Day 15 in Fasting Triglycerides	Fasting serum triglycerides measured in milligrams per deciliter (mg/dL).	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).	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).	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).	Baseline (Day 0) and Day 15

Collaborators and Investigators

• Sponsor: IMDEA Food
• Investigators: Principal Investigator: Alberto Davalos, IMDEA Food

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2025
• Primary Completion (Actual): March 14, 2025
• Study Completion (Actual): March 14, 2025

Study Registration Dates

• First Submitted: April 29, 2025
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 21/745-E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No