HealthyNCT07456267
Plant miRNAs In Human Plasma After Broccoli Consumption
A study testing Broccoli consumption in people with Healthy, run by IMDEA Food at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Broccoli consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 14 Feb 2025to 14 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Broccoli consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli consumptionDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Broccoli consumption | Experimental | 200g daily broccoli consumption, for 2 weeks Receives: Dietary Supplement: Broccoli consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline (Day -1) and Day 15
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline (Day 0) and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start14 Feb 2025
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMDEA Food
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Davalos Herrera, IMDEA Food
- Investigators
- Alberto Davalos, Principal investigator, IMDEA Food
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456267
- Sponsor's protocol ID
- 21/745-E
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection Of Plant miRNAs After Broccoli Consumption In Human Plasma: Role Of "Cross-Kingdom" Regulation
- ClinicalTrials.gov ID
- NCT07456267
- Acronym / sponsor ID
- 21/745-E
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IMDEA FoodUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Broccoli consumption | Experimental | Dietary Supplement: Broccoli consumption200g daily broccoli consumption, for 2 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broccoli consumptionClinical-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. | Dietary supplement | Broccoli consumption |
Primary outcome
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).
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).
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).
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.
5 secondary outcomes
Change From Baseline to Day 15 in Fasting Total Cholesterol
Time frame: Baseline (Day 0) and Day 15
Change From Baseline to Day 15 in Fasting Triglycerides
Time frame: Baseline (Day 0) and Day 15
Change From Baseline to Day 15 in Fasting Plasma Glucose
Time frame: Baseline (Day 0) and Day 15
Change From Baseline to Day 15 in Aspartate Aminotransferase (AST)
Time frame: Baseline (Day 0) and Day 15
Change From Baseline to Day 15 in Alanine Aminotransferase (ALT)
Time frame: Baseline (Day 0) and Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Davalos principal investigator
IMDEA Food
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broccoli consumption in people with Healthy, run by IMDEA Food at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Broccoli-derived microRNAs Detected in Plasma (RNA Sequencing) (time frame: Baseline (pre-consumption), 1 Hour, 3 Hours, and 6 Hours Post-consumption). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.