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Completed

NCT Number: NCT07456267

Plant miRNAs In Human Plasma After Broccoli Consumption

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imdea-Food

Madrid, 28049, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of Broccoli-derived microRNAs Detected in Plasma (RNA Sequencing)

    Time frame: 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).

  2. Change From Baseline to Day 15 in Plasma Level of Selected Broccoli-derived microRNAs (qRT-PCR)

    Time frame: 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).

  3. Change From Baseline to Day 15 in Gut Microbiota Alpha Diversity (Shannon Index)

    Time frame: 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).

  4. Number of Broccoli-derived microRNAs Detected in Stool (RNA Sequencing)

    Time frame: 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 outcomes

  1. Change From Baseline to Day 15 in Fasting Total Cholesterol

    Time frame: Baseline (Day 0) and Day 15

    Fasting serum total cholesterol measured in milligrams per deciliter (mg/dL) using standard clinical chemistry methods.

  2. Change From Baseline to Day 15 in Fasting Triglycerides

    Time frame: Baseline (Day 0) and Day 15

    Fasting serum triglycerides measured in milligrams per deciliter (mg/dL).

  3. Change From Baseline to Day 15 in Fasting Plasma Glucose

    Time frame: Baseline (Day 0) and Day 15

    Fasting plasma glucose measured in milligrams per deciliter (mg/dL).

  4. Change From Baseline to Day 15 in Aspartate Aminotransferase (AST)

    Time frame: Baseline (Day 0) and Day 15

    Serum AST measured in units per liter (U/L).

  5. Change From Baseline to Day 15 in Alanine Aminotransferase (ALT)

    Time frame: Baseline (Day 0) and Day 15

    Serum ALT measured in units per liter (U/L).

Sponsors and collaborators

Lead sponsor

IMDEA Food

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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