Obesity and OverweightEarly Phase 1SANO-ChronicNCT06964659
Chronic Intervention With Sulforaphane-Smart® in Overweight and Obese Adults
A Early Phase 1 study testing Sulforaphan-Smart® formula in people with Obesity and Overweight, run by Mª Jesús Periago at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- Sulforaphan-Smart® formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2025to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Edificio Pleyades-Vitalys 5ª y 6ª planta, Campus Universitario, Espinardo
Murcia, Spain, 30100
Lorena Sánchez Martínez, PhD, +34 868 889628, lorena.sanchez14@um.es
Rocío González Barrio, PhD, Associate Professor, +34 868 889641, rgbarrio@um.es
About this study
Official title: Sulforaphane-Smart® on Lipid and Glucose Metabolism, Inflammation, Adiposity and Microbiome of Overweight Adults "SANO"
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).
Read the 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.
- Conditions
- Obesity and Overweight
- Being tested
- Sulforaphan-Smart® formula, Control (placebo) group
- Keywords
- Glucosinolates, Isothiocyanates, Sulforaphane, Gut microbiota, Inflammation, Oxidative stress
- Medical subject headings
- Obesity, Overweight, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulforaphan-Smart® formulaDietary supplement
Also called GLS/ITC group
Volunteers will intake a daily dose of Sulforaphan-Smart® pill for 12 weeks (84 days)
Control (placebo) groupOther
Also called PL group
Volunteers will intake a daily dose of placebo pill for 12 weeks (84 days)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control (placebo) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
The measurement of the body mass index (BMI) will be carried out throughout the intervention study, in both experimental and placebo groups. For this purpose, weight (kg) and height (cm) will be registered and used to calculate the total BMI (kg/m^2).
Measured: 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 measurements of the waist-to-hip ratio (WHR) will be carried out throughout the intervention study, in both experimental and placebo groups. The circumference of the waist and hip will be registered (cm) and used to calculate the WHR.
Measured: 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
The fat mass percentage will measure using a Tanita DC-430MAP body scale, in both experimental and placebo groups, to determine possible changes after the daily intake of Sulforaphane Smart® formula.
Measured: 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
The fat free mass percentage will measure with a Tanita DC-430MAP body scale in both experimental and placebo groups, to determine possible changes after the daily intake of Sulforaphane Smart® formula.
Measured: 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
The body water percentage will measure with a Tanita DC-430MAP body scale in both experimental and placebo groups, to determine possible changes after the daily intake of Sulforaphane Smart® formula.
Measured: 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
The body bone mass percentage will measure with a Tanita DC-430MAP body scale, in both experimental and placebo groups, to determine possible changes after the daily intake of Sulforaphane Smart® formula.
Measured: 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
The visceral fat index will measure with a Tanita DC-430MAP body scale, in both experimental and placebo groups, to determine possible changes after the daily intake of Sulforaphane Smart® formula.
Measured: 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
The volunteers will provide information about the 24-hours food intake questionaries before the collection of the biological samples, to quantify the intake on nutrients and energy.
Measured: 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
All volunteers will fill a "Mediterranean Diet adherence" questionnaire to evaluate the adherence of the diet profile.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study startJul 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mª Jesús Periago
- Sponsor type
- University, hospital or other
- Collaborators
- Ingredalia Company, Spanish National Research Council (CEBAS-CSIC)
- Responsible party
- Sponsor-investigator, Mª Jesús Periago, Universidad de Murcia
- Investigators
- Rocío González Barrio, PhD, Principal investigator, Universidad de MurciaMaría Jesús Periago Castón, PhD, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964659
- Sponsor's protocol ID
- SANO Project (Chronic)
- Other IDs
- CPP2022-009528
- Acronym
- SANO-Chronic
- Status last verified
- May 2025
- First submitted
- 7 Mar 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sulforaphane-Smart® on Lipid and Glucose Metabolism, Inflammation, Adiposity and Microbiome of Overweight Adults "SANO"
- ClinicalTrials.gov ID
- NCT06964659
- Acronym / sponsor ID
- SANO-Chronic / SANO Project (Chronic)
- Conditions
- Obesity and Overweight
- Keywords
- Glucosinolates, Isothiocyanates, Sulforaphane, Gut microbiota, Inflammation, Oxidative stress
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mª Jesús PeriagoUniversity, hospital or other
- Collaborators
- Ingredalia Company, Spanish National Research Council (CEBAS-CSIC)
- Study start
- Jul 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sulforaphan-Smart® formula | Experimental | Dietary Supplement: Sulforaphan-Smart® formulaThe 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. |
| Control/Placebo | Placebo comparator | Other: Control (placebo) groupThe 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- BMI: low and normal weight
- Age different from that required
- Digestive or intestinal diseases
- Having antibiotics during the previous three months
- Having pharmacological treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulforaphan-Smart® formulaAlso: GLS/ITC groupVolunteers will intake a daily dose of Sulforaphan-Smart® pill for 12 weeks (84 days) | Dietary supplement | Sulforaphan-Smart® formula |
| Control (placebo) groupAlso: PL groupVolunteers will intake a daily dose of placebo pill for 12 weeks (84 days) | Other | Control/Placebo |
Primary outcome
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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
Time frame: 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
Time frame: 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).
9 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- A systematic review about the nutritional interest of glucosinolates, including human intervention studiesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rocío González Barrio, PhD principal investigator
Universidad de Murcia
María Jesús Periago Castón, PhD principal investigator
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sulforaphan-Smart® formula in people with Obesity and Overweight, run by Mª Jesús Periago at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorena Sánchez Martínez, PhD (+34 868 889628, lorena.sanchez14@um.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.