Chronic Intervention With Sulforaphane-Smart® in Overweight and Obese Adults (SANO-Chronic)

Mª Jesús Periago

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Obesity and Overweight

Treatments: Other: Control (placebo) group; Dietary Supplement: Sulforaphan-Smart® formula

Study type: Interventional

Funder types: Other

Identifiers

NCT06964659

SANO Project (Chronic)

CPP2022-009528 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Sulforaphan-Smart® formula

Experimental group

Description:

The volunteers of the experimental group will intake of Sulforaphan-Smart® formula to evaluate if the chronic consumption of GSL/ITC, during the intervention period of 12 weeks, could modulate the glucidic and lipid metabolism, the biomarkers related to chronic inflammation and oxidative stress and the gut microbiota in overweight and obese volunteers.

Treatment:

Dietary Supplement: Sulforaphan-Smart® formula

Control/Placebo

Placebo Comparator group

Description:

The volunteers of placebo group will intake the placebo formula or pill to objectively separate the effects of the drug under study (Sulforaphane Smart® formula) during the intervention period of 12 weeks.

Treatment:

Other: Control (placebo) group