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

Mª Jesús Periago

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Healthy

Treatments

Dietary Supplement: Sulforaphan Smart®

Study type

Interventional

Funder types

Other

Identifiers

NCT06856486

SANO Bioavailability Project

CPP2022-009528 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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