Plant miRNAs In Human Plasma After Broccoli Consumption

NCT07456267 | Completed

• 1 other identifier: 21/745-E
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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 Fasting Plasma Glucose

  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

Study Arms (1)

Broccoli consumption

EXPERIMENTAL

200g daily broccoli consumption, for 2 weeks

Dietary Supplement: Broccoli consumption

Interventions

Broccoli consumption DIETARY_SUPPLEMENT

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.

Broccoli consumption

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IMDEA Food: lead

Study Sites (1)

Imdea-Food

Madrid, Madrid, 28049, Spain

Location

Study Officials

• Alberto Davalos

  IMDEA Food

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Investigator

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: March 6, 2026
• Study Start: February 14, 2025
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: March 6, 2026

Record last verified: 2025-04

Locations

ES (1)