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

NCT06964659 | Not Yet Recruiting Early Phase 1

• 2 other identifiers: SANO Project (Chronic)CPP2022-009528
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity and Overweight

Keywords

Glucosinolates; Isothiocyanates; Sulforaphane; Gut microbiota; Inflammation; Oxidative stress

Outcome Measures

Primary Outcomes (12)

• Changes in the concentration of plasmatic glucose

  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.

  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

  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.

  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

  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.

  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

  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.

  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

  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.

  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

  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.

  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

  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.

  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

  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.

  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

  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

  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

  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.

  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).

• Changes in microbiota

  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.

  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).

• Changes of SCFAs in feces

  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).

  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 (9)

• Changes in the body mass index

  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

  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

  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

  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

  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).

Study Arms (2)

Sulforaphan-Smart® formula

EXPERIMENTAL

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.

Dietary Supplement: Sulforaphan-Smart® formula

Control/Placebo

PLACEBO COMPARATOR

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.

Other: Control (placebo) group

Interventions

Sulforaphan-Smart® formula DIETARY_SUPPLEMENT

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

Also known as: GLS/ITC group

Sulforaphan-Smart® formula

Control (placebo) group OTHER

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

Also known as: PL group

Control/Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mª Jesús Periago: lead
• Ingredalia Company: collaborator
• Spanish National Research Council (CEBAS-CSIC): collaborator

Study Sites (1)

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

Murcia, Spain, 30100, Spain

Location

Related Links

• A systematic review about the nutritional interest of glucosinolates, including human intervention studies

MeSH Terms

Conditions

Obesity; Overweight; Inflammation

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Rocío González Barrio, PhD

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

• María Jesús Periago Castón, PhD

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorena Sánchez Martínez, PhD

CONTACT

+34 868 889628; lorena.sanchez14@um.es

Rocío González Barrio, PhD

CONTACT

+34 868 889641; rgbarrio@um.es

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Full Professor of Food Science and Nutrition

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: May 9, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05

Locations

ES (1)