Acute Intervention with Sulforaphane-Smart®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2025-12-31

Brief Summary

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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).

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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sulforaphan-Smart® formula

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

Group Type EXPERIMENTAL

Sulforaphan Smart®

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes