Acute Intervention with Sulforaphane-Smart® (SANO-Acute)
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:
- 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).
Study Overview
Status
Conditions
Intervention / Treatment
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 To evaluate the bioavailability of the bioactive compounds (GLS/ITCs) blood samples will be withdrawn at 0, 6 and 24 h, whereas urine samples will be collected at 0, 6 and 24 h after ingestion of Sulforaphan-Smart® pill.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 Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Lorena Sánchez Martínez
- Phone Number: +34 868 889628
- Email: lorena.sanchez14@um.es
Study Contact Backup
- Name: Rocío González Barrio
- Phone Number: +34 868 889641 +34 868 889641
- Email: rgbarrio@um.es
Study Locations
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-
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Murcia, Spain, 30100
- Edificio Pleyades-Vitalys 5ª y 6ª planta, Campus Universitario, Espinardo
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Contact:
- Lorena Sánchez Martínez, PhD
- Phone Number: +34 868 889628
- Email: lorena.sanchez14@um.es
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Contact:
- Rocío González Barrio, PhD, Associate Professor
- Phone Number: +34 868 889641
- Email: rgbarrio@um.es
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Contact:
- Maria Jesús Periago Castón, PhD, Full Professor
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Contact:
- Rocío González Barrio, PhD, Associated Professor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Sulforaphan-Smart® formula
Intake of the Sulforaphan-Smart® formula to evaluate its pharmacokinetics in biological samples of plasma and urine.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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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)
Time Frame: Analysis of metabolites of GSL/ITCs after 6 hours taking the Sulforaphane-Smart pill.
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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.
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Analysis of metabolites of GSL/ITCs after 6 hours taking the Sulforaphane-Smart pill.
|
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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.
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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.
|
Analysis of metabolites of GSL/ITCs after 24 hours taking the Sulforaphane-Smart pill.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rocío González Barrio, Universidad de Murcia
- Principal Investigator: María Jesús Periago Castón, Universidad de Murcia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SANO Bioavailability Project
- CPP2022-009528 (Other Identifier: Ministerio de Ciencia, Innovación y Universidades)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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