HealthyEarly Phase 1SANO-AcuteNCT06856486
Acute Intervention with Sulforaphane-Smart®
A Early Phase 1 study testing Sulforaphan Smart® in people with Healthy, run by Mª Jesús Periago at 1 site in Spain.
Trial summary
The Sulforaphane-Smartt® formula is a pill, patented by the company INGREDALIA, prepared with broccoli by-products which have been concentrated and enriched in glucosinolates/isothiocyanates (GLS/ITCs). Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sulforaphan Smart®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2025to Dec 2025
- Phase
- Early Phase 1
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: normal weight or overweight volunteers
- No digestive or intestinal diseases
- Age between 20 and 45 years old
- Not having antibiotics during the previous three months
- Not having pharmacological treatment
- Not being smokers
- Not following restrictive diets (vegetarian/vegan diet) or nutritional supplement
Who cannot join
- BMI: low weight and obesity
- Age different from that required
- Digestive or intestinal diseases
- Having antibiotics during the previous three months
- Having pharmacological treatments
- Following restrictive diets (vegetarian/vegan diet) or nutritional supplement
- Smoker
- Menopause
Trial locations and contacts
1 site in 1 country.
Spain1 site
Edificio Pleyades-Vitalys 5ª y 6ª planta, Campus Universitario, Espinardo
Murcia, 30100
Lorena Sánchez Martínez, PhD, +34 868 889628, lorena.sanchez14@um.es
Rocío González Barrio, PhD, Associate Professor, +34 868 889641, rgbarrio@um.es
About this study
Official title: Sulforaphane-Smart® on Lipid and Glucose Metabolism, Inflammation, Adiposity and Microbiome of Overweight Adults "SANO"
The Sulforaphane-Smartt® formula is a pill, patented by the company INGREDALIA, prepared with broccoli by-products which have been concentrated and enriched in glucosinolates/isothiocyanates (GLS/ITCs).
The goal of this intervention study with the Sulforaphane-Smartt® formula is to study the bioavailability of the bioactive compounds in normal weight and overweight adults. The main questions it aims to answer are:
Read more
- Determine the absorption curve of the bioactive compounds (GLS/ITCs).
- Analyze the metabolites in plasma and urine of the GLS/ITCs to know the bioavailability.
This acute intervention is designed to take a single fasting dose of Sulforaphan-Smart®, collecting plasma and urine samples to study free and conjugated metabolites of GLS/ITC.
There is not a comparison group, since the acute intervention study with the Sulforaphane-Smart® is designed to determine the bioavailability of the bioactive compounds (GLS/ITCs).
Read the detailed description
Sulforaphan-Smart® is a formula patented by the company INGREDALA (patented by INGREDALIA: EP3123874B1). This clinical trial will provide information about the bioavailability of the bioactive compounds of this formula (GLS/ITCs). The results of this research project will give us the possibility of obtaining a nutraceutical product based on the increasing the technology readiness level (TRL) from the current TRL5 to TRL6-7.
An acute intervention study will be conducted with 20 participants, normal-weight and overweight volunteers of both sexes, to evaluate the bioavailability and the absorption curve of the GSL/ITCs by the analysis of metabolites in urine and blood. These metabolites are considered biomarkers of intake and will allow to study the bioavailability of the bioactive compounds of the Sulforaphan-Smart® formula.
Participants will be informed about the study design and activities and will signed the informed consent. They will follow a diet free of Cruciferous during 72 h before the beginning of the study, as washout period. After that participants will take a single dose of Sulforaphane-Smart® pill on a fasting regimen. To evaluate the bioavailability of the bioactive compounds (GLS/ITCs) blood samples will be withdrawn at 0, 6 and 24 h, whereas urine samples will be collected at 0, 6 and 24 h after ingestion of Sulforaphan-Smart® pill.
Free and conjugated metabolites will be analysed in plasma and urine by UHPLC-QqQ-MS/MS following their fragmentation patterns, with the aim to evaluate the bioavailability of the GSL/ITCs of the Sulforaphan-Smart® formula.
- Conditions
- Healthy
- Being tested
- Sulforaphan Smart®
- Keywords
- Glucosinolates, Isothiocyanates, Sulforaphane, bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulforaphan Smart®Dietary supplement
Fasting volunteers will intake the Sulforaphan Smart® pill, and blood and urine samples will be taken at the beginning of the intervention (Time 0 hours, before intake the pill), and 6 and 24 hours after its intake the pills (Time 6 hours and Time 24 hours) to measure the biomarkers related to the bioavailability of GSL/ITCs.
| Study group | Role | What they receive |
|---|---|---|
| Sulforaphan-Smart® formula | Experimental | Intake of the Sulforaphan-Smart® formula to evaluate its pharmacokinetics in biological samples of plasma and urine. Receives: Dietary Supplement: Sulforaphan Smart® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of free and conjugated metabolites of GLs/ITCs in urine and plasma at the beginning of the intervention (Time 0 hours)
Samples of blood and urine will be taken before the intake of the pill. The investigators will analyse the profile of free and conjugated metabolites in plasma and urinary using UHPLC-QqQ-MS/MS following their fragmentation patterns.
Measured: Analysis of metabolites of GSL/ITCs before intake the Sulforaphane-Smart pill.
Characterization of free and conjugated metabolites of GLs/ITCs in urine and plasma after 6 hours of the intake of pill (Time 6 hours)
Samples of blood and urine will be collected after 6 hours taking the pill. The investigators will analyze metabolites in plasma and urinary using UHPLC-QqQ-MS/MS following their fragmentation patterns.
Measured: Analysis of metabolites of GSL/ITCs after 6 hours taking the Sulforaphane-Smart pill.
Characterization of free and conjugated metabolites of GLs/ITCs in urine and plasma after 24 hours of the intake of pill (Time 24 hours)
Samples of blood and urine will be taken 24 hours after taking the pill. The investigators will analyse the profile of free and conjugated metabolites in plasma and urinary using UHPLC-QqQ-MS/MS following their fragmentation patterns.
Measured: Analysis of metabolites of GSL/ITCs after 24 hours taking the Sulforaphane-Smart pill.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mª Jesús Periago
- Sponsor type
- University, hospital or other
- Collaborators
- Ingredalia Company, Spanish National Research Council (CEBAS-CSIC)
- Responsible party
- Sponsor-investigator, Mª Jesús Periago, Universidad de Murcia
- Investigators
- Rocío González Barrio, Principal investigator, Universidad de MurciaMaría Jesús Periago Castón, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856486
- Sponsor's protocol ID
- SANO Bioavailability Project
- Other IDs
- CPP2022-009528
- Acronym
- SANO-Acute
- Status last verified
- Mar 2024
- First submitted
- 10 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sulforaphane-Smart® on Lipid and Glucose Metabolism, Inflammation, Adiposity and Microbiome of Overweight Adults "SANO"
- ClinicalTrials.gov ID
- NCT06856486
- Acronym / sponsor ID
- SANO-Acute / SANO Bioavailability Project
- Conditions
- Healthy
- Keywords
- Glucosinolates, Isothiocyanates, Sulforaphane, bioavailability
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mª Jesús PeriagoUniversity, hospital or other
- Collaborators
- Ingredalia Company, Spanish National Research Council (CEBAS-CSIC)
- Study start
- Mar 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Mar 2025 (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.
The Sulforaphane-Smartt® formula is a pill, patented by the company INGREDALIA, prepared with broccoli by-products which have been concentrated and enriched in glucosinolates/isothiocyanates (GLS/ITCs).
The goal of this intervention study with the Sulforaphane-Smartt® formula is to study the bioavailability of the bioactive compounds in normal weight and overweight adults. The main questions it aims to answer are:
- Determine the absorption curve of the bioactive compounds (GLS/ITCs).
- Analyze the metabolites in plasma and urine of the GLS/ITCs to know the bioavailability.
This acute intervention is designed to take a single fasting dose of Sulforaphan-Smart®, collecting plasma and urine samples to study free and conjugated metabolites of GLS/ITC.
There is not a comparison group, since the acute intervention study with the Sulforaphane-Smart® is designed to determine the bioavailability of the bioactive compounds (GLS/ITCs).
Detailed description
Sulforaphan-Smart® is a formula patented by the company INGREDALA (patented by INGREDALIA: EP3123874B1). This clinical trial will provide information about the bioavailability of the bioactive compounds of this formula (GLS/ITCs). The results of this research project will give us the possibility of obtaining a nutraceutical product based on the increasing the technology readiness level (TRL) from the current TRL5 to TRL6-7.
An acute intervention study will be conducted with 20 participants, normal-weight and overweight volunteers of both sexes, to evaluate the bioavailability and the absorption curve of the GSL/ITCs by the analysis of metabolites in urine and blood. These metabolites are considered biomarkers of intake and will allow to study the bioavailability of the bioactive compounds of the Sulforaphan-Smart® formula.
Participants will be informed about the study design and activities and will signed the informed consent. They will follow a diet free of Cruciferous during 72 h before the beginning of the study, as washout period. After that participants will take a single dose of Sulforaphane-Smart® pill on a fasting regimen. To evaluate the bioavailability of the bioactive compounds (GLS/ITCs) blood samples will be withdrawn at 0, 6 and 24 h, whereas urine samples will be collected at 0, 6 and 24 h after ingestion of Sulforaphan-Smart® pill.
Free and conjugated metabolites will be analysed in plasma and urine by UHPLC-QqQ-MS/MS following their fragmentation patterns, with the aim to evaluate the bioavailability of the GSL/ITCs of the Sulforaphan-Smart® formula.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sulforaphan-Smart® formula | Experimental | Dietary Supplement: Sulforaphan Smart®Intake of the Sulforaphan-Smart® formula to evaluate its pharmacokinetics in biological samples of plasma and urine. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- BMI: normal weight or overweight volunteers
- No digestive or intestinal diseases
- Age between 20 and 45 years old
- Not having antibiotics during the previous three months
- Not having pharmacological treatment
Key exclusion criteria (8 listed)
- BMI: low weight and obesity
- Age different from that required
- Digestive or intestinal diseases
- Having antibiotics during the previous three months
- Having pharmacological treatments
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 |
|---|---|---|
| Sulforaphan Smart®Fasting volunteers will intake the Sulforaphan Smart® pill, and blood and urine samples will be taken at the beginning of the intervention (Time 0 hours, before intake the pill), and 6 and 24 hours after its intake the pills (Time 6 hours and Time 24 hours) to measure the biomarkers related to the bioavailability of GSL/ITCs. | Dietary supplement | Sulforaphan-Smart® formula |
Primary outcome
Characterization of free and conjugated metabolites of GLs/ITCs in urine and plasma at the beginning of the intervention (Time 0 hours)
Time frame: Analysis of metabolites of GSL/ITCs before intake the Sulforaphane-Smart pill.
Samples of blood and urine will be taken before the intake of the pill. The investigators will analyse the profile of free and conjugated metabolites in plasma and urinary using UHPLC-QqQ-MS/MS following their fragmentation patterns.
Characterization of free and conjugated metabolites of GLs/ITCs in urine and plasma after 6 hours of the intake of pill (Time 6 hours)
Time frame: Analysis of metabolites of GSL/ITCs after 6 hours taking the Sulforaphane-Smart pill.
Samples of blood and urine will be collected after 6 hours taking the pill. The investigators will analyze metabolites in plasma and urinary using UHPLC-QqQ-MS/MS following their fragmentation patterns.
Characterization of free and conjugated metabolites of GLs/ITCs in urine and plasma after 24 hours of the intake of pill (Time 24 hours)
Time frame: Analysis of metabolites of GSL/ITCs after 24 hours taking the Sulforaphane-Smart pill.
Samples of blood and urine will be taken 24 hours after taking the pill. The investigators will analyse the profile of free and conjugated metabolites in plasma and urinary using UHPLC-QqQ-MS/MS following their fragmentation patterns.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Review about the clinical trials with broccoli sprouts or sulforaphane to investigate the beneficial effect for human healthLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Rocío González Barrio principal investigator
Universidad de Murcia
María Jesús Periago Castón principal investigator
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sulforaphan Smart® in people with Healthy, run by Mª Jesús Periago 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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 Mar 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorena Sánchez Martínez (+34 868 889628, lorena.sanchez14@um.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of free and conjugated metabolites of GLs/ITCs in urine and plasma at the beginning of the intervention (Time 0 hours) (time frame: Analysis of metabolites of GSL/ITCs before intake the Sulforaphane-Smart pill.). The study lists 3 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 4 Mar 2025; AzTrials last refreshed its copy on 28 Oct 2026.