An Early Phase 1 interventional study of Sulforaphan Smart® in Healthy, sponsored by Mª Jesús Periago. Not yet recruiting at 1 site in Spain. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Mª Jesús Periago · Early Phase 1, Interventional, and Other
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:
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).
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 To evaluate the bioavailability of the bioactive compounds (GLS/ITCs) blood samples will be withdrawn at 0, 6 and 24 h, whereas urine samples will be collected at 0, 6 and 24 h after ingestion of Sulforaphan-Smart® pill.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.
Mª Jesús Periago is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intake of the Sulforaphan-Smart® formula to evaluate its pharmacokinetics in biological samples of plasma and urine.
Dietary Supplement: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Analysis of metabolites of GSL/ITCs after 24 hours taking the Sulforaphane-Smart pill.
Plan to share: Undecided
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mª Jesús Periago