Clinical trial NCT06964659: Chronic Intervention With Sulforaphane-Smart® in Overweight and Obese Adults
Official title: Sulforaphane-Smart® on Lipid and Glucose Metabolism, Inflammation, Adiposity and Microbiome of Overweight Adults "SANO"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Obesity and Overweight
Keywords: Glucosinolates
Isothiocyanates
Sulforaphane
Gut microbiota
Inflammation
Oxidative stress
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
Collaborators: name: Ingredalia Company
name: Spanish National Research Council (CEBAS-CSIC)
First posted: 2025-05-09
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The volunteers will be randomly assigned to the intervention groups. The experimental group (with 20 volunteers) intake daily the Sulforaphane-Smart® pill during 12 weeks, and the placebo group (with 20 volunteers) intake the placebo pill in parallel during the same period.
Primary purpose: OTHER

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).

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.

Eligibility criteria: Inclusion Criteria:

* BMI: overweight and obese (BMI 25-34,9 Kg/m2)
* 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 and normal weight
* 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

Primary outcomes:
measure: Changes in the concentration of plasmatic glucose
timeFrame: Plasmatic glucose concentration will be analysed at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of intervention (Time 12 weeks).
measure: Changes in the concentration of plasmatic insulin
timeFrame: Plasmatic insulin concentration will be analysed at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of intervention (Time 12 weeks).
measure: Changes in the HOMA-IR
timeFrame: HOMA-IR index will be calculated at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of intervention (Time 12 weeks).
measure: Changes in the concentration of lipid metabolism parameters of plasma
timeFrame: Lipid metabolism parameters will be analysed at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of intervention (Time 12 weeks).
measure: Changes of C-reactive protein in plasma
timeFrame: C-reactive protein will be analysed at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of intervention (Time 12 weeks).
measure: Changes of TNF-α in plasma
timeFrame: TNF-α will be analysed at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of intervention (Time 12 weeks).
measure: Changes of Interleukins in plasma
timeFrame: Interleukins will be analysed at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of intervention (Time 12 weeks).
measure: Changes of MDA in plasma
timeFrame: MDA will be analysed at the beginning of the intervention (initial time), at six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks).
measure: Changes of isoprostanes concentration in urine
timeFrame: Isosprotanes concentration will be analysed in urine at the beginning of the intervention (initial time), at six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks).
measure: Changes of MDA concentration in urine
timeFrame: MDA concentration will be analysed at the beginning of the intervention (initial time), at six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks).
measure: Changes in microbiota
timeFrame: The composition of the gut microbiota will be analysed at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks).
measure: Changes of SCFAs in feces
timeFrame: The concentration of SCFAs in feces will be analysed at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks).
Secondary outcomes:
measure: Changes in the body mass index
timeFrame: BMI will be taken at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks).
measure: Changes in the waist-to-hip ratio
timeFrame: The WHR will be measured at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks).
measure: Changes in body fat mass percentage
timeFrame: Fat mass percentage will be registered at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks).
measure: Changes in body fat free mass percentage
timeFrame: Fat free mass percentage will be registered at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks).
measure: Changes in body water percentage
timeFrame: Body water percentage will be registered at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks).
measure: Changes in body bone mass percentage
timeFrame: Body bone mass percentage will be registered at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks).
measure: Changes in visceral fat index
timeFrame: Visceral fat index will be registered at the beginning of the intervention (initial time), after six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks).
measure: Evaluation of food intake questionnaire
timeFrame: The 24-hours food intake questionnaire will be registered at the beginning (initial time), after six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks)
measure: Evaluation of the dietary habits
timeFrame: Mediterranean Diet Adherence Questionnaire will be completed at the beginning of the intervention (initial time), at six weeks (Time 6 weeks) and at the end of the intervention (Time 12 weeks).
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Edificio Pleyades-Vitalys 5ª y 6ª planta, Campus Universitario, Espinardo
Study officials:
affiliation: Universidad de Murcia
name: Rocío González Barrio, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Murcia
name: María Jesús Periago Castón, PhD
role: PRINCIPAL_INVESTIGATOR
References: