Nutrition, HealthyPRO-BROCNCT06561893
Effect of L. Plantarum Probiotic Supplementation on Broccoli Sulforaphane Bioavailability: Randomised Double-blind Placebo-controlled Crossover Study
A study testing Broccoli sprouts extract supplementation in people with Nutrition, Healthy, run by University of Exeter at 2 sites in United Kingdom.
Trial summary
Broccoli has the precursor of an active compound (sulforaphane) that has shown a wide range of health promoting benefits. Sulforaphane formation depends on the conversion of glucoraphanin (precursor) by myrosinase enzyme. Thus, the bioavailability of sulforaphane is affected by myrosinase activity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Broccoli sprouts extract supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Oct 2024to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults (male and female)
- age range of 18-65 years
- BMI range of 18-30 kg/m2
Who cannot join
- have been on a course of antibiotics within the period of the past 3 months.
- have allergies or intolerance towards probiotic substances or broccoli used in the study and/or food intolerances associated with gastrointestinal upset.
- have been taking pre- or probiotics supplements regularly during the last month prior (this does not include foods containing probiotics and/or prebiotics foods)
- are following any restricting diet (e.g., vegan, FODMAP, etc.).
- have a gastrointestinal inflammatory condition (e.g., irritable bowel syndrome, inflammatory bowel diseases, coeliac diseases, constipation, etc.).
- have a medical condition or take medication for any heart, endocrine, or metabolic condition, such as high blood pressure, high cholesterol, insulin resistance, or diabetes, or autoimmune disease.
- are a pregnant and/or breastfeeding.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Department of Public Health and Sport Sciences, University of Exeter Medical School, Faculty of Health and Life Sciences, University of Exeter
Exeter, Devon, EX1 2 LU
Richard's Building, St Luke's Campus
Exeter, Devon, EX2 4TA
About this study
Broccoli has the precursor of an active compound (sulforaphane) that has shown a wide range of health promoting benefits. Sulforaphane formation depends on the conversion of glucoraphanin (precursor) by myrosinase enzyme. Thus, the bioavailability of sulforaphane is affected by myrosinase activity. Some bacteria, such as L. plantarum (probiotic), have shown they can also convert glucoraphanin to sulforaphane in vitro. This study investigates the effect of short-term L. plantarum supplementation on broccoli sulforaphane bioavailability in humans using a randomised double-blind placebo-controlled crossover trial.
Read the detailed description
Brassicas (i.e. broccoli, kale, cabbage) are a group of edible plants that contain a phytochemical called glucoraphanin that upon enzymatic hydrolysis forms the bioactive form sulforaphane. Sulforaphane has shown consistent in vitro and in vivo (animals) anti-cancer activity. The enzyme responsible for this conversion is called myrosinase; however, the enzymatic activity of myrosinase can be affected by several biological factors (e.g. plant variety, growth conditions, etc...) and food processing (e.g. cooking, drying, etc...). Broccoli is one of the richest sources of glucoraphanin, but its myrosinase activity can be easily lost during cooking: 10 minutes at 70 °C reduces the enzyme activity by 95%. This means broccoli prepared this way will contain little to no biologically active sulforaphane. Therefore, is important to find strategies to increase the bioavailability of sulforaphane in broccoli and other brassicas for human consumption.
Certain bacteria have shown myrosinase-like activity and were able to convert glucoraphanin to sulforaphane in vitro, one of these bacteria is Lactiplantibacillus plantarum. This bacterium is present in the human gut, however, there is a large biological variability in the prevalence of this bacteria between individuals. Several human studies have demonstrated that chronic (\>1 week) consumption of probiotic supplements containing L. plantarum was able to increase the presence of this bacterium in human gut participants. Thus, the investigators aim to test if supplementing participants with L. plantarum will increase the bioavailability of sulforaphane, compared to placebo.
- Conditions
- Nutrition, Healthy
- Being tested
- Broccoli sprouts extract supplementation
- Keywords
- broccoli, sulforaphane, probiotic, gut microbiota, L. plantarum, bioavailability, cross-over trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli sprouts extract supplementationDietary supplement
Intake of broccoli sprouts extract supplement (Brand: Source Naturals, Scotts Valley, CA 95066 - USA) in an acute dose (84 umol of glucoraphanin) before and after 2 weeks of probiotic or placebo supplementation, to assess sulforaphane bioavailability measured in urine metabolites
| Study group | Role | What they receive |
|---|---|---|
| Probiotic (L. plantarum) supplementation | Active comparator | Dose: 20 Billion CFU/day for 14 days (total of two pills of 10 Billion CFU) Receives: Dietary Supplement: Broccoli sprouts extract supplementation |
| Placebo (dextrose) supplementation | Placebo comparator | Dose: 700 mg of dextrose (total of two pills; 2 x 350 mg pills) Receives: Dietary Supplement: Broccoli sprouts extract supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of sulforaphane
Bioavailability (%) of sulforaphane (will be estimated by dividing the cumulative amount of sulforaphane mercapturic acid excreted in urine in 24 h by the consumed amount of glucoraphanin (Vermeulen et al., 2008)) before and after chronic consumption of L. plantarum compared with placebo.
Measured: From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition
Secondary outcomes (3)
Sulforaphane pharmacokinetics: Area under the curve
Measurement of the definite integral of the concentration of sulforaphane (and its metabolites) in blood plasma as a function of time.
Measured: From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition.
Sulforaphane pharmacokinetics: Cmax
Measurement of the maximum plasma concentration (Cmax) of sulforaphane (and its metabolites) indicating the value of the highest concentrations reached in the plasma.
Measured: From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition.
Sulforaphane pharmacokinetics: Tmax
Measurement of the time taken for sulforaphane (and its metabolites) to reach the maximum concentration (Cmax) after administration of the supplement that needs to be absorbed.
Measured: From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Oct 2024
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised Double-blind Placebo-controlled Crossover Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Queensland, PepsiCo, Inc.
- Responsible party
- Sponsor
- Investigators
- Luciana Torquati, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561893
- Sponsor's protocol ID
- 6190780
- Acronym
- PRO-BROC
- Status last verified
- Apr 2026
- First submitted
- 18 Jun 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant details (name, age, sex, etc.) will be stored in a password secured as per university guidelines. Participants will be allocated a code (ID number) at enrolment, and this will be used to refer to them hereafter. Data will be collected and entered under a participant's ID number, and analysed and stored as such. Only researchers listed in this application will have access to all data. Presentations, reports and publications will only include aggregated data with no personal or individual data included. Anonymised databases will be made available upon request or deposit in open repository upon request of journal.
Publications
Oloyede OO, Wagstaff C, Methven L. The Impact of Domestic Cooking Methods on Myrosinase Stability, Glucosinolates and Their Hydrolysis Products in Different Cabbage (Brassica oleracea) Accessions. Foods. 2021 Nov 24;10(12):2908. doi: 10.3390/foods10122908.
PubMed 34945460Gonzalez F, Quintero J, Del Rio R, Mahn A. Optimization of an Extraction Process to Obtain a Food-Grade Sulforaphane-Rich Extract from Broccoli (Brassica oleracea var. italica). Molecules. 2021 Jul 1;26(13):4042. doi: 10.3390/molecules26134042.
PubMed 34279379Iahtisham-Ul-Haq, Khan S, Awan KA, Iqbal MJ. Sulforaphane as a potential remedy against cancer: Comprehensive mechanistic review. J Food Biochem. 2022 Mar;46(3):e13886. doi: 10.1111/jfbc.13886. Epub 2021 Aug 5.
PubMed 34350614Surono IS, Simatupang A, Kusumo PD, Waspodo P, Verbruggen S, Verhoeven J, Venema K. Effect of Different Functional Food Supplements on the Gut Microbiota of Prediabetic Indonesian Individuals during Weight Loss. Nutrients. 2022 Feb 13;14(4):781. doi: 10.3390/nu14040781.
PubMed 35215431Ye JH, Huang LY, Terefe NS, Augustin MA. Fermentation-based biotransformation of glucosinolates, phenolics and sugars in retorted broccoli puree by lactic acid bacteria. Food Chem. 2019 Jul 15;286:616-623. doi: 10.1016/j.foodchem.2019.02.030. Epub 2019 Feb 14.
PubMed 30827654Cai YX , Augustin MA , Jegasothy H , Wang JH , Terefe NS . Mild heat combined with lactic acid fermentation: a novel approach for enhancing sulforaphane yield in broccoli puree. Food Funct. 2020 Jan 29;11(1):779-786. doi: 10.1039/c9fo02089f.
PubMed 31922158Vermeulen M, Klopping-Ketelaars IW, van den Berg R, Vaes WH. Bioavailability and kinetics of sulforaphane in humans after consumption of cooked versus raw broccoli. J Agric Food Chem. 2008 Nov 26;56(22):10505-9. doi: 10.1021/jf801989e.
PubMed 18950181
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of L. Plantarum Probiotic Supplementation on Broccoli Sulforaphane Bioavailability: Randomised Double-blind Placebo-controlled Crossover Study
- ClinicalTrials.gov ID
- NCT06561893
- Acronym / sponsor ID
- PRO-BROC / 6190780
- Conditions
- Nutrition, Healthy
- Keywords
- broccoli, sulforaphane, probiotic, gut microbiota, L. plantarum, bioavailability, cross-over trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- The University of Queensland, PepsiCo, Inc.
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 20 Aug 2024 (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.
Broccoli has the precursor of an active compound (sulforaphane) that has shown a wide range of health promoting benefits. Sulforaphane formation depends on the conversion of glucoraphanin (precursor) by myrosinase enzyme. Thus, the bioavailability of sulforaphane is affected by myrosinase activity. Some bacteria, such as L. plantarum (probiotic), have shown they can also convert glucoraphanin to sulforaphane in vitro. This study investigates the effect of short-term L. plantarum supplementation on broccoli sulforaphane bioavailability in humans using a randomised double-blind placebo-controlled crossover trial.
Detailed description
Brassicas (i.e. broccoli, kale, cabbage) are a group of edible plants that contain a phytochemical called glucoraphanin that upon enzymatic hydrolysis forms the bioactive form sulforaphane. Sulforaphane has shown consistent in vitro and in vivo (animals) anti-cancer activity. The enzyme responsible for this conversion is called myrosinase; however, the enzymatic activity of myrosinase can be affected by several biological factors (e.g. plant variety, growth conditions, etc...) and food processing (e.g. cooking, drying, etc...). Broccoli is one of the richest sources of glucoraphanin, but its myrosinase activity can be easily lost during cooking: 10 minutes at 70 °C reduces the enzyme activity by 95%. This means broccoli prepared this way will contain little to no biologically active sulforaphane. Therefore, is important to find strategies to increase the bioavailability of sulforaphane in broccoli and other brassicas for human consumption.
Certain bacteria have shown myrosinase-like activity and were able to convert glucoraphanin to sulforaphane in vitro, one of these bacteria is Lactiplantibacillus plantarum. This bacterium is present in the human gut, however, there is a large biological variability in the prevalence of this bacteria between individuals. Several human studies have demonstrated that chronic (\>1 week) consumption of probiotic supplements containing L. plantarum was able to increase the presence of this bacterium in human gut participants. Thus, the investigators aim to test if supplementing participants with L. plantarum will increase the bioavailability of sulforaphane, compared to placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Double-blind Placebo-controlled Crossover Study
| Arm | Type | Receives |
|---|---|---|
| Probiotic (L. plantarum) supplementation | Active comparator | Dietary Supplement: Broccoli sprouts extract supplementationDose: 20 Billion CFU/day for 14 days (total of two pills of 10 Billion CFU) |
| Placebo (dextrose) supplementation | Placebo comparator | Dietary Supplement: Broccoli sprouts extract supplementationDose: 700 mg of dextrose (total of two pills; 2 x 350 mg pills) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy adults (male and female)
- age range of 18-65 years
- BMI range of 18-30 kg/m2
Key exclusion criteria (7 listed)
- have been on a course of antibiotics within the period of the past 3 months.
- have allergies or intolerance towards probiotic substances or broccoli used in the study and/or food intolerances associated with gastrointestinal upset.
- have been taking pre- or probiotics supplements regularly during the last month prior (this does not include foods containing probiotics and/or prebiotics foods)
- are following any restricting diet (e.g., vegan, FODMAP, etc.).
- have a gastrointestinal inflammatory condition (e.g., irritable bowel syndrome, inflammatory bowel diseases, coeliac diseases, constipation, etc.).
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 |
|---|---|---|
| Broccoli sprouts extract supplementationIntake of broccoli sprouts extract supplement (Brand: Source Naturals, Scotts Valley, CA 95066 - USA) in an acute dose (84 umol of glucoraphanin) before and after 2 weeks of probiotic or placebo supplementation, to assess sulforaphane bioavailability measured in urine metabolites | Dietary supplement | Placebo (dextrose) supplementation, Probiotic (L. plantarum) supplementation |
Primary outcome
Bioavailability of sulforaphane
Time frame: From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition
Bioavailability (%) of sulforaphane (will be estimated by dividing the cumulative amount of sulforaphane mercapturic acid excreted in urine in 24 h by the consumed amount of glucoraphanin (Vermeulen et al., 2008)) before and after chronic consumption of L. plantarum compared with placebo.
3 secondary outcomes
Sulforaphane pharmacokinetics: Area under the curve
Time frame: From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition.
Sulforaphane pharmacokinetics: Cmax
Time frame: From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition.
Sulforaphane pharmacokinetics: Tmax
Time frame: From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 34945460Oloyede OO, Wagstaff C, Methven L. The Impact of Domestic Cooking Methods on Myrosinase Stability, Glucosinolates and Their Hydrolysis Products in Different Cabbage (Brassica oleracea) Accessions. Foods. 2021 Nov 24;10(12):2908. doi: 10.3390/foods10122908.
- Background: PubMed 34279379Gonzalez F, Quintero J, Del Rio R, Mahn A. Optimization of an Extraction Process to Obtain a Food-Grade Sulforaphane-Rich Extract from Broccoli (Brassica oleracea var. italica). Molecules. 2021 Jul 1;26(13):4042. doi: 10.3390/molecules26134042.
- Background: PubMed 34350614Iahtisham-Ul-Haq, Khan S, Awan KA, Iqbal MJ. Sulforaphane as a potential remedy against cancer: Comprehensive mechanistic review. J Food Biochem. 2022 Mar;46(3):e13886. doi: 10.1111/jfbc.13886. Epub 2021 Aug 5.
- Background: PubMed 35215431Surono IS, Simatupang A, Kusumo PD, Waspodo P, Verbruggen S, Verhoeven J, Venema K. Effect of Different Functional Food Supplements on the Gut Microbiota of Prediabetic Indonesian Individuals during Weight Loss. Nutrients. 2022 Feb 13;14(4):781. doi: 10.3390/nu14040781.
- Background: PubMed 30827654Ye JH, Huang LY, Terefe NS, Augustin MA. Fermentation-based biotransformation of glucosinolates, phenolics and sugars in retorted broccoli puree by lactic acid bacteria. Food Chem. 2019 Jul 15;286:616-623. doi: 10.1016/j.foodchem.2019.02.030. Epub 2019 Feb 14.
- Background: PubMed 31922158Cai YX , Augustin MA , Jegasothy H , Wang JH , Terefe NS . Mild heat combined with lactic acid fermentation: a novel approach for enhancing sulforaphane yield in broccoli puree. Food Funct. 2020 Jan 29;11(1):779-786. doi: 10.1039/c9fo02089f.
- Background: PubMed 18950181Vermeulen M, Klopping-Ketelaars IW, van den Berg R, Vaes WH. Bioavailability and kinetics of sulforaphane in humans after consumption of cooked versus raw broccoli. J Agric Food Chem. 2008 Nov 26;56(22):10505-9. doi: 10.1021/jf801989e.
- Individual participant dataSharing planned: No. Participant details (name, age, sex, etc.) will be stored in a password secured as per university guidelines. Participants will be allocated a code (ID number) at enrolment, and this will be used to refer to them hereafter. Data will be collected and entered under a participant's ID number, and analysed and stored as such. Only researchers listed in this application will have access to all data. Presentations, reports and publications will only include aggregated data with no personal or individual data included. Anonymised databases will be made available upon request or deposit in open repository upon request of journal.
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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. This study is not recruiting at the moment.
Luciana Torquati, PhD principal investigator
University of Exeter
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broccoli sprouts extract supplementation in people with Nutrition, Healthy, run by University of Exeter at 2 sites in United Kingdom.
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 3 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: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability of sulforaphane (time frame: From baseline to the end of each condition at 2 weeks, followed by 2 weeks of wash-out, and before and after the next condition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06561893, which also lists 7 linked publications.
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 5 May 2026.