Acute Intervention with Sulforaphane-Smart®

NCT06856486 | Not Yet Recruiting Early Phase 1

• 2 other identifiers: SANO Bioavailability ProjectCPP2022-009528
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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). 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).

Conditions

Healthy

Keywords

Glucosinolates; Isothiocyanates; Sulforaphane; bioavailability

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Analysis of metabolites of GSL/ITCs after 24 hours taking the Sulforaphane-Smart pill.

Study Arms (1)

Sulforaphan-Smart® formula

EXPERIMENTAL

Intake of the Sulforaphan-Smart® formula to evaluate its pharmacokinetics in biological samples of plasma and urine.

Dietary Supplement: Sulforaphan Smart®

Interventions

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.

Sulforaphan-Smart® formula

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mª Jesús Periago: lead
• Ingredalia Company: collaborator
• Spanish National Research Council (CEBAS-CSIC): collaborator

Study Sites (1)

Edificio Pleyades-Vitalys 5ª y 6ª planta, Campus Universitario, Espinardo

Murcia, 30100, Spain

Location

Related Links

• Review about the clinical trials with broccoli sprouts or sulforaphane to investigate the beneficial effect for human health

Study Officials

• Rocío González Barrio

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

• María Jesús Periago Castón

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorena Sánchez Martínez

CONTACT

+34 868 889628; lorena.sanchez14@um.es

Rocío González Barrio

CONTACT

+34 868 889641; rgbarrio@um.es

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Full Professor of Food Science and Nutrition

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 4, 2025
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 4, 2025

Record last verified: 2024-03

Locations

ES (1)