Clinical trial

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

Opening soon · Early Phase 1 · 1 countries · Registry ID NCT06964659

Opening soonEarly Phase 1Interventional

What this study is 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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 45 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity and Overweight

Full registry 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

Treatments and study arms

Sulforaphan-Smart® formula

Dietary Supplement

Volunteers will intake a daily dose of Sulforaphan-Smart® pill for 12 weeks (84 days)

Control (placebo) group

Other

Volunteers will intake a daily dose of placebo pill for 12 weeks (84 days)

Primary outcomes

Changes in the concentration of plasmatic glucosePlasmatic 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).

Glucose concentration will be analyzed in plasma samples of both experimental and placebo groups, to determine the effect of the daily intake of Sulforaphan-Smart® formula.

Changes in the concentration of plasmatic insulinPlasmatic 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).

Insulin concentration will be analyzed in the plasma samples in both experimental and placebo groups, to determine the effect of the daily intake of Sulforaphan-Smart® forrmula.

Changes in the HOMA-IRHOMA-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).

The HOMA-IR index will be calculated using the plasmatic concentration of glucose and insulin, to determine the insulin resistance index in both experimental and placebo groups after the daily intake of Sulforaphan-Smart® formula.

Changes in the concentration of lipid metabolism parameters of plasmaLipid 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).

Lipid metabolism parameters of plasma including total cholesterol, LDL-C, HDL-C and triglycerides will be analyzed in the plasma samples in both experimental and placebo groups, to determine the effect of the daily intake of Sulforaphan-Smart® formula.

Changes of C-reactive protein in plasmaC-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).

The concentration of C-reactive protein will be analyzed, in plasma samples in both experimental and placebo groups as biomarker of inflammation, to evaluate the effect of the daily consumption of Sulforaphan-Smart®. The concentration of this biomarker will be analyzed using an ELISA kit, following the manufacturer's instructions.

Changes of TNF-α in plasmaTNF-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).

Tumor Necrosis Factor alfa (TNF-α) will be determined in samples, of both experimental and placebo groups, to determine the effect of the daily consumption of Sulforaphan-Smart® in chronic inflammation. The concentration of this biomarker will be analyzed using an ELISA kit, following the manufacturer's instructions.

Changes of Interleukins in plasmaInterleukins 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).

Interleukins (IL-6, IL-1β and IL-8) will be analysed in samples of both experimental and placebo groups, to evaluate the effect of the daily consumption of Sulforaphan-Smart® on chronic inflammation. The concentration of these biomarkers will be analyzed using an ELISA kit, following the manufacturer's instructions.

Changes of MDA in plasmaMDA 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).

Malonaldehyde (MDA) will be analysed in plasma samples of bth experimental and placebo groups to evaluate the effect of the daily consumption of Sulforaphan-Smart® formula on the oxidative stress. For this purpose MDA concentration will be analysed in plasma samples using an ELISA kit, following the manufacturer's instructions.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Edificio Pleyades-Vitalys 5ª y 6ª planta, Campus Universitario, Espinardo🇪🇸 Murcia, Spain, Spain

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Lorena Sánchez Martínez, PhDContact

Email · Call +34 868 889628

Rocío González Barrio, PhD, Associate ProfessorContact

Email · Call +34 868 889641

María Jesús Periago Castón, PhD, Full ProfessorPrincipal Investigator