Acute Intervention with Sulforaphane-Smart® (SANO-Acute)

February 27, 2025 updated by: Mª Jesús Periago

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

Not yet recruiting

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

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Rocío González Barrio
  • Phone Number: +34 868 889641 +34 868 889641
  • Email: rgbarrio@um.es

Study Locations

  • Spain
      • Murcia, Spain, 30100
        • Edificio Pleyades-Vitalys 5ª y 6ª planta, Campus Universitario, Espinardo
        • Contact:
        • Contact:
          • Rocío González Barrio, PhD, Associate Professor
          • Phone Number: +34 868 889641
          • Email: rgbarrio@um.es
        • Contact:
          • Maria Jesús Periago Castón, PhD, Full Professor
        • Contact:
          • Rocío González Barrio, PhD, Associated Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Sulforaphan-Smart® formula
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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)
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.
Analysis of metabolites of GSL/ITCs after 24 hours taking the Sulforaphane-Smart pill.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mª Jesús Periago

Collaborators

Ingredalia Company
Spanish National Research Council (CEBAS-CSIC)

Investigators

  • Principal Investigator: Rocío González Barrio, Universidad de Murcia
  • Principal Investigator: María Jesús Periago Castón, Universidad de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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