Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 11:54 AM
Study NCT ID:
NCT06964659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-09
First Post:
2025-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Intervention With Sulforaphane-Smart® in Overweight and Obese Adults
Sponsor:
Mª Jesús Periago
Organization:
Study Overview
Official Title:
Sulforaphane-Smart® on Lipid and Glucose Metabolism, Inflammation, Adiposity and Microbiome of Overweight Adults "SANO"
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SANO-Chronic
Brief Summary:
The Sulforaphane-Smart® 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 is to evaluate if the chronic consumption of GSL/ITC (Sulforaphane Smart® formula) could modulate the biomarkers related to chronic inflammation, oxidative stress and gut microbiota in overweight and obese volunteers.
In order to reach this goal, the volunteers will take daily the Sulforaphane Smart® formula during 12 weeks (total of 84 days). Anthropometric measurements will be taken and biological samples of blood, urine and feces will be collected at the beginning of the intervention (initial time), after six weeks of the intervention (Time 6 weeks) and at the end of the intervention (Time 12 weeks).
The goal of this intervention study is to evaluate if the chronic consumption of GSL/ITC (Sulforaphane Smart® formula) could modulate the biomarkers related to chronic inflammation, oxidative stress and gut microbiota in overweight and obese volunteers.
In order to reach this goal, the volunteers will take daily the Sulforaphane Smart® formula during 12 weeks (total of 84 days). Anthropometric measurements will be taken and biological samples of blood, urine and feces will be collected at the beginning of the intervention (initial time), after six weeks of the intervention (Time 6 weeks) and at the end of the intervention (Time 12 weeks).
Detailed Description:
Sulforaphan-Smart® is formula patented by the company INGREDALA (patented by INGREDALIA: EP3123874B1). This clinical trial will provide information about the beneficial effects of the consumption of Sulforaphan Smart® on glucidic and lipid metabolism, inflammation, adiposity, antioxidant status and microbiome of adults with overweight or obesity.
The study will be conducted with a total of 40 adults with overweight and obesity (BMI 25 to 34.9 Kg/m2) from both sexes. Volunteers will be divided into two groups according to the randomized-controlled and parallel design protocol, with two arms (experimental and placebo groups) with 20 volunteers per group.
During 12 weeks the experimental group will intake one daily dose of Sulforaphan Smart®, meanwhile the placebo group will intake one daily dose of placebo. Biological samples (blood, urine and feces) will be taken during the intervention and the following experimental parameters will be taken at the beginning (initial time), after six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks):
* Anthropometric study will be performed with a Tanita Body Weight Scale (DC-430MAP).
* Biochemical parameters of plasma related to glucidic and lipid metabolism.
* Analysis of Biomarkers of inflammation in plasma (C-reactive protein, adiponectin, IL-6, IL-1β and IL-8).
* Analysis of oxidative stress biomarkers in plasma and urine: determination of isoprostanes and malonaldehyde concentrations.
* Analysis of fecal microbiota by 16SrRNA sequencing after extraction of total DNA from feces.
* Analysis of Short Chain Fatty Acids by GLC in feces as metabolites of the fecal microbiota.
The study will be conducted with a total of 40 adults with overweight and obesity (BMI 25 to 34.9 Kg/m2) from both sexes. Volunteers will be divided into two groups according to the randomized-controlled and parallel design protocol, with two arms (experimental and placebo groups) with 20 volunteers per group.
During 12 weeks the experimental group will intake one daily dose of Sulforaphan Smart®, meanwhile the placebo group will intake one daily dose of placebo. Biological samples (blood, urine and feces) will be taken during the intervention and the following experimental parameters will be taken at the beginning (initial time), after six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks):
* Anthropometric study will be performed with a Tanita Body Weight Scale (DC-430MAP).
* Biochemical parameters of plasma related to glucidic and lipid metabolism.
* Analysis of Biomarkers of inflammation in plasma (C-reactive protein, adiponectin, IL-6, IL-1β and IL-8).
* Analysis of oxidative stress biomarkers in plasma and urine: determination of isoprostanes and malonaldehyde concentrations.
* Analysis of fecal microbiota by 16SrRNA sequencing after extraction of total DNA from feces.
* Analysis of Short Chain Fatty Acids by GLC in feces as metabolites of the fecal microbiota.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CPP2022-009528 | OTHER | Ministerio de Ciencia, Innovación y Universidades | View |