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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Study 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).

Eligibility

Primary outcome measure(s)

• Changes in the concentration of plasmatic glucose — 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).
  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 insulin — 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).
  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-IR — 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).
  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 plasma — 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).
  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 plasma — 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).
  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 plasma — 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).
  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 plasma — 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).
  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 plasma — 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).
  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.
• Changes of isoprostanes concentration in urine — 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).
  Isoprostanes concentration will be analysed in urine samples of both experimental and placebo groups , with the aim to evaluate the effect of the daily consumption of Sulforaphan-Smart® formula on oxidative stress. This biomarker will be analysed using an ELISA kit, following the manufacturer's instructions
• Changes of MDA concentration in urine — 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).
  Malonaldehyde (MDA) concentration will be analysed in urine samples of both experimental and placebo groups, with the aim to evaluate the effect of the daily consumption of Sulforaphan-Smart® formula on oxidative stress. The concentration of this biomarker will be determined using an ELISA kit, following the manufacturer's instructions.
• Changes in microbiota — 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).
  The effect of the daily intake of Sulforaphan-Smart® formula on gut microbiota will be determined by 16S rRNA sequencing, after the extraction of total faecal DNA.
• Changes of SCFAs in feces — 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).
  The changes in the concentration of short-chain fatty acids (SCFAs) in feces after the daily intake of Sulforaphan-Smart® formula will be analysed by gas chromatography (GC-FID).

Trial sites (1)

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