HealthyBOBSNCT02300324
The Bioavailability Of Sulforaphane From Broccoli Soups Study (BOBS)
A study testing Standard broccoli and stilton soup, Beneforte broccoli and stilton soup and Beneforte Extra broccoli and stilton soup in people with Healthy, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial summary
There is current evidence that suggests eating cruciferous vegetables like broccoli, cauliflower, cabbage is beneficial to our health as they contain compounds which are thought to reduce the risk of diseases such as cancer and cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Standard broccoli and stilton soup, Beneforte broccoli and stilton soup and Beneforte Extra broccoli and stilton soup
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Aug 2015
- 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
- Men and women
- Aged 18-65 years
- Non-smokers
- Those that live within 40 miles of IFR
- Those who like broccoli + stilton soups
Who cannot join
- Those unwilling/unable to provide urine and blood samples
- Results of the clinical screening indicate, or are judged by the HNU medical advisor to be indicative of a health problem which could compromise the well-being of the participants if they participated, or which would affect the study outcome.
- Those whose vein status is assessed by HNU senior research nurse as unsuitable for cannulation
- Known history of fainting when blood samples are taken, feel unwell or faint during any clinical study day procedures at the HNU
- Women who are or have been pregnant within the last 12 months or who are breast feeding.
- Those diagnosed with any long-term medical condition (e.g. diabetes, haemophilia, cardiovascular disease, glaucoma, anaemia) or requiring medication that may affect the study outcome.
Show all 23Show fewer
- Smokers
- Those taking dietary supplements or herbal remedies which may affect the study outcome - unless the participant is willing to discontinue taking them for 1 month prior to starting study. Please note that some supplements may not affect the study and this will be assessed on an individual basis
- Those allergic to any of the ingredients in broccoli + stilton soups
- Participants allergic to members of the Brassica family, e.g. mustard allergy (often combined with sensitivity to mugwort pollen, cabbage and peach) or to Brassica pollens (mustard or rapeseed).
- Those taking any prescribed or non-prescribed medication (short or long term), which may affect the study data or participant's wellbeing. This will be assessed by the HNU medical advisor on an individual basis.
- Those on an anti-coagulant therapy or have had anti-coagulant therapy in the past 3 months.
- Parallel participation in another research project that involves dietary intervention
- Any person related to or living with any member of the study team
- Participation in another research project, which involves blood sampling within the last four months unless total blood from both studies does not exceed 470mL (unless the participants are willing to wait 4 months and then be re-screened).
- Those unwilling to provide GP's contact details
- Those unable to provide written informed consent
- Those not suitable to take part in this study because of the screening results
- Those who have donated or intend to donate blood within 16 weeks prior to the study or during the study
- Those with a body mass index (BMI, kg/m2) ≤20 or ≥35 kg/m2
- Depressed or elevated blood pressure measurements (<90/50 or 95/55 if symptomatic or >160/100)
- Those that have used antibiotics within the previous one month or on long-term antibiotic therapy.
- Those who are unable to completely finish the 300g portion of broccoli + stilton soup on any of the study days as this will affect study data.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Food Research
Norwich, Norfolk, NR4 7UY
About this study
Official title: An Intervention Study to Assess the Bioavailability of Sulforaphane Delivered by Glucoraphanin-enriched Broccoli Soups in Healthy Subjects
There is current evidence that suggests eating cruciferous vegetables like broccoli, cauliflower, cabbage is beneficial to our health as they contain compounds which are thought to reduce the risk of diseases such as cancer and cardiovascular diseases. Cruciferous vegetables are able to deliver in our body a group of compounds called isothiocyanates (ITCs) that are thought to be responsible of their health-promoting effects. Sulforaphane (SF) from broccoli is one of the most studied ITCs and its anticancer properties have been extensively investigated in in vitro and in vivo models.
The investigators propose to undertake an intervention study to measure the bioavailability of SF from the soups used in another intervention study called ESCAPE. The investigators would like to investigate the rate and extent to which SF reaches the systemic circulation and is excreted in urine by measuring SF and its metabolites in plasma and urine samples collected from apparently healthy participants after consumption of the three types of broccoli + stilton soups. The three types of soups are standard broccoli + stilton soups and two high-glucoraphanin (SF precursor) broccoli + stilton soups which are able to deliver different levels of SF.
This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC) and Prostate Cancer foundation (PCF).
Read the detailed description
This study will be a randomized, double-blinded, three-phase crossover trial which will investigate the bioavailability of SF following consumption of broccoli + stilton soup containing different concentrations of glucoraphanin.
The study population will consist of non-smoking men and women aged between 18 and 65 years old. Participants will undergo three phases separated by a minimum of two weeks (wash-out period). Each phase will consist of a 48 hour pre-intervention diet restriction, a study day involving an 8 hour cannulation at the Human Nutrition Unit (HNU) of the Institute of Food Research (IFR) and collection of a 24 hour urine and blood sample the following morning. Participants will be randomly allocated to one of the three soups in each phase. The following soups will be tested in the three phases: i) 300g standard broccoli + stilton soup, ii) 300g Beneforte® broccoli + stilton soup, iii) 300g Beneforte Extra broccoli + stilton soup.
Beneforte and Beneforte extra broccoli are especially cultivated to deliver high sulforaphane levels after consumption. All the three broccoli varieties have the same appearance and flavour thus enabling a blinded human intervention study to be undertaken. Broccoli soups will be manufactured by a food company that supplies soups to the leading supermarket retailers in the United Kingdom.
Each phase will consist of a 48 hour pre-intervention diet restriction, a study day (study day 1) comprising of approximately a nine hour stay at the HNU which will involve cannulation. The following morning participants will visit the HNU for up to 1 hour for collection of a single blood sample at 24 hour post-dose followed by breakfast. During study day 1, eleven 10ml blood samples will be collected over the course of the day from participants at the following timepoints: 0, 30, 45, 60, 90, 120, 180, 240, 360, 480 mins and a 24 hour blood sample. Six urine samples will be collected at the following timepoints: 0, 0-2, 2-4, 4-6, 6-8, 8-24 hours.
The three phases will be separated by a minimum of a two week washout period. For the duration of the study, participants will be required to follow a glucosinolate-free diet for a total of nine days which will be three days per phase. The three days are split into 48 hours (2 days) prior to the study day, 24 hours (1 day) on the study day as well as the following morning until the 24 hour blood and urine sample have been collected. After the 24 hour urine and blood samples have been collected, participants can resume their normal diet for a minimum of two weeks until 48 hours prior to their next study day. This will reduce the contribution of glucosinolate from other foods having an impact on the results of the study. The involvement of the participants will last approximately 11-12 weeks.
- Conditions
- Healthy
- Being tested
- Standard broccoli and stilton soup, Beneforte broccoli and stilton soup, Beneforte Extra broccoli and stilton soup
- Keywords
- bioavailability, Beneforte, sulforaphane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard broccoli and stilton soupDietary supplement
Participants will be randomised to eat one portion (300g) of broccoli soup for each phase.
Beneforte broccoli and stilton soupDietary supplement
Participants will be randomised to eat one portion (300g) of broccoli soup for each phase.
Beneforte Extra broccoli and stilton soupDietary supplement
Participants will be randomised to eat one portion (300g) of broccoli soup for each phase.
| Study group | Role | What they receive |
|---|---|---|
| Standard v Beneforte v Beneforte Extra | Experimental | This is a randomized, double-blinded, three-phase crossover trial investigating the bioavailability of SF following consumption of three types of broccoli + stilton soup containing different concentrations of glucoraphanin. The three types of soup are standard broccoli and stilton soup, beneforte broccoli and stilton soup, and beneforte extra broccoli and stilton soup. Receives: Dietary Supplement: Standard broccoli and stilton soup; Dietary Supplement: Beneforte broccoli and stilton soup; Dietary Supplement: Beneforte Extra broccoli and stilton soup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total excretion of SF in 24 hour urine samples
To measure the total excretion of SF in urine collected for 24 hours after consumption of one pot (300g) of three types of broccoli + stilton soup containing different concentrations of glucoraphanin, SF precursor.
Measured: 0, 0-2, 2-4, 4-6, 6-8, 8-24 hours
Secondary outcomes (1)
Plasma concentration of SF and its metabolites
- To measure SF and its metabolites in plasma following consumption of one pot (300g) of three types of broccoli + stilton soup containing different concentrations of glucoraphanin.
Measured: 0, 30, 45, 60, 90, 120, 180, 240, 360, 480 mins and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Prostate Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Richard Mithen, PhD, Principal investigator, Quadram Institute Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300324
- Sponsor's protocol ID
- 14/EE/1121
- Acronym
- BOBS
- Status last verified
- Sep 2015
- First submitted
- 20 Nov 2014
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sivapalan T, Melchini A, Saha S, Needs PW, Traka MH, Tapp H, Dainty JR, Mithen RF. Bioavailability of Glucoraphanin and Sulforaphane from High-Glucoraphanin Broccoli. Mol Nutr Food Res. 2018 Sep;62(18):e1700911. doi: 10.1002/mnfr.201700911. Epub 2018 Mar 8.
PubMed 29266773
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention Study to Assess the Bioavailability of Sulforaphane Delivered by Glucoraphanin-enriched Broccoli Soups in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02300324
- Acronym / sponsor ID
- BOBS / 14/EE/1121
- Conditions
- Healthy
- Keywords
- bioavailability, Beneforte, sulforaphane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Prostate Cancer Foundation
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Nov 2014 (estimated)
- 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.
There is current evidence that suggests eating cruciferous vegetables like broccoli, cauliflower, cabbage is beneficial to our health as they contain compounds which are thought to reduce the risk of diseases such as cancer and cardiovascular diseases. Cruciferous vegetables are able to deliver in our body a group of compounds called isothiocyanates (ITCs) that are thought to be responsible of their health-promoting effects. Sulforaphane (SF) from broccoli is one of the most studied ITCs and its anticancer properties have been extensively investigated in in vitro and in vivo models.
The investigators propose to undertake an intervention study to measure the bioavailability of SF from the soups used in another intervention study called ESCAPE. The investigators would like to investigate the rate and extent to which SF reaches the systemic circulation and is excreted in urine by measuring SF and its metabolites in plasma and urine samples collected from apparently healthy participants after consumption of the three types of broccoli + stilton soups. The three types of soups are standard broccoli + stilton soups and two high-glucoraphanin (SF precursor) broccoli + stilton soups which are able to deliver different levels of SF.
This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC) and Prostate Cancer foundation (PCF).
Detailed description
This study will be a randomized, double-blinded, three-phase crossover trial which will investigate the bioavailability of SF following consumption of broccoli + stilton soup containing different concentrations of glucoraphanin.
The study population will consist of non-smoking men and women aged between 18 and 65 years old. Participants will undergo three phases separated by a minimum of two weeks (wash-out period). Each phase will consist of a 48 hour pre-intervention diet restriction, a study day involving an 8 hour cannulation at the Human Nutrition Unit (HNU) of the Institute of Food Research (IFR) and collection of a 24 hour urine and blood sample the following morning. Participants will be randomly allocated to one of the three soups in each phase. The following soups will be tested in the three phases: i) 300g standard broccoli + stilton soup, ii) 300g Beneforte® broccoli + stilton soup, iii) 300g Beneforte Extra broccoli + stilton soup.
Beneforte and Beneforte extra broccoli are especially cultivated to deliver high sulforaphane levels after consumption. All the three broccoli varieties have the same appearance and flavour thus enabling a blinded human intervention study to be undertaken. Broccoli soups will be manufactured by a food company that supplies soups to the leading supermarket retailers in the United Kingdom.
Each phase will consist of a 48 hour pre-intervention diet restriction, a study day (study day 1) comprising of approximately a nine hour stay at the HNU which will involve cannulation. The following morning participants will visit the HNU for up to 1 hour for collection of a single blood sample at 24 hour post-dose followed by breakfast. During study day 1, eleven 10ml blood samples will be collected over the course of the day from participants at the following timepoints: 0, 30, 45, 60, 90, 120, 180, 240, 360, 480 mins and a 24 hour blood sample. Six urine samples will be collected at the following timepoints: 0, 0-2, 2-4, 4-6, 6-8, 8-24 hours.
The three phases will be separated by a minimum of a two week washout period. For the duration of the study, participants will be required to follow a glucosinolate-free diet for a total of nine days which will be three days per phase. The three days are split into 48 hours (2 days) prior to the study day, 24 hours (1 day) on the study day as well as the following morning until the 24 hour blood and urine sample have been collected. After the 24 hour urine and blood samples have been collected, participants can resume their normal diet for a minimum of two weeks until 48 hours prior to their next study day. This will reduce the contribution of glucosinolate from other foods having an impact on the results of the study. The involvement of the participants will last approximately 11-12 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard v Beneforte v Beneforte Extra | Experimental | Dietary Supplement: Standard broccoli and stilton soup, Dietary Supplement: Beneforte broccoli and stilton soup, Dietary Supplement: Beneforte Extra broccoli and stilton soupThis is a randomized, double-blinded, three-phase crossover trial investigating the bioavailability of SF following consumption of three types of broccoli + stilton soup containing different concentrations of glucoraphanin. The three types of soup are standard broccoli and stilton soup, beneforte broccoli and stilton soup, and beneforte extra broccoli and stilton soup. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women
- Aged 18-65 years
- Non-smokers
- Those that live within 40 miles of IFR
- Those who like broccoli + stilton soups
Key exclusion criteria (23 listed)
- Those unwilling/unable to provide urine and blood samples
- Results of the clinical screening indicate, or are judged by the HNU medical advisor to be indicative of a health problem which could compromise the well-being of the participants if they participated, or which would affect the study outcome.
- Those whose vein status is assessed by HNU senior research nurse as unsuitable for cannulation
- Known history of fainting when blood samples are taken, feel unwell or faint during any clinical study day procedures at the HNU
- Women who are or have been pregnant within the last 12 months or who are breast feeding.
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 |
|---|---|---|
| Standard broccoli and stilton soupParticipants will be randomised to eat one portion (300g) of broccoli soup for each phase. | Dietary supplement | Standard v Beneforte v Beneforte Extra |
| Beneforte broccoli and stilton soupParticipants will be randomised to eat one portion (300g) of broccoli soup for each phase. | Dietary supplement | Standard v Beneforte v Beneforte Extra |
| Beneforte Extra broccoli and stilton soupParticipants will be randomised to eat one portion (300g) of broccoli soup for each phase. | Dietary supplement | Standard v Beneforte v Beneforte Extra |
Primary outcome
Total excretion of SF in 24 hour urine samples
Time frame: 0, 0-2, 2-4, 4-6, 6-8, 8-24 hours
To measure the total excretion of SF in urine collected for 24 hours after consumption of one pot (300g) of three types of broccoli + stilton soup containing different concentrations of glucoraphanin, SF precursor.
1 secondary outcome
Plasma concentration of SF and its metabolites
Time frame: 0, 30, 45, 60, 90, 120, 180, 240, 360, 480 mins and 24 hours
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 17 Sep 2015.
- Derived from this study: PubMed 29266773Sivapalan T, Melchini A, Saha S, Needs PW, Traka MH, Tapp H, Dainty JR, Mithen RF. Bioavailability of Glucoraphanin and Sulforaphane from High-Glucoraphanin Broccoli. Mol Nutr Food Res. 2018 Sep;62(18):e1700911. doi: 10.1002/mnfr.201700911. Epub 2018 Mar 8.
Related trials for Healthy
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy
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.
Richard Mithen, PhD principal investigator
Quadram Institute Bioscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard broccoli and stilton soup, Beneforte broccoli and stilton soup and Beneforte Extra broccoli and stilton soup in people with Healthy, run by Quadram Institute Bioscience at 1 site 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 5 inclusion and 23 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 17 Sep 2015. 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 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. 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?
Total excretion of SF in 24 hour urine samples (time frame: 0, 0-2, 2-4, 4-6, 6-8, 8-24 hours). 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 NCT02300324, which also lists 1 linked publication.
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 17 Sep 2015.