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"

Overview

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.

Interventions

• Dietary supplement Sulforaphan-Smart® formula
  Volunteers will intake a daily dose of Sulforaphan-Smart® pill for 12 weeks (84 days)
• Other Control (placebo) group
  Volunteers will intake a daily dose of placebo pill for 12 weeks (84 days)

Primary outcome measures

• Changes in the concentration of plasmatic glucose [Time frame: 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).]
• Changes in the concentration of plasmatic insulin [Time frame: 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).]
• Changes in the HOMA-IR [Time frame: 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).]
• Changes in the concentration of lipid metabolism parameters of plasma [Time frame: 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).]
• Changes of C-reactive protein in plasma [Time frame: 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).]
• Changes of TNF-α in plasma [Time frame: 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).]
• Changes of Interleukins in plasma [Time frame: 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).]
• Changes of MDA in plasma [Time frame: 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).]
• Changes of isoprostanes concentration in urine [Time frame: 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).]
• Changes of MDA concentration in urine [Time frame: 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).]

Secondary outcome measures (9)

• Changes in the body mass index [Time frame: 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).]
• Changes in the waist-to-hip ratio [Time frame: 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).]
• Changes in body fat mass percentage [Time frame: 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).]
• Changes in body fat free mass percentage [Time frame: 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).]
• Changes in body water percentage [Time frame: 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).]
• Changes in body bone mass percentage [Time frame: 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).]
• Changes in visceral fat index [Time frame: 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).]
• Evaluation of food intake questionnaire [Time frame: 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)]
• Evaluation of the dietary habits [Time frame: 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).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Spain · 1 center

• Edificio Pleyades-Vitalys 5ª y 6ª planta, Campus Universitario, Espinardo — Murcia

Identifiers

NCT: NCT06964659 · SANO Project (Chronic) · CPP2022-009528

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗