Healthy VolunteersNCT01357070
Effect of Broccoli Sprout on Blood Levels of Sulforaphane to Reduce Responsiveness of Immune System
A study testing Brocco-sprout homogenate and Alfalfa sprout homogenate in people with Healthy Volunteers, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The investigators suggest that inducing anti-oxidant enzymes indirectly may be an effective means of providing vascular protection. Sulforaphane, a naturally occurring compound found in green vegetables (including broccoli, brussel sprouts and cauliflower) is able to protect against cell inflammatory stress by… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Brocco-sprout homogenate and Alfalfa sprout homogenate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to Jan 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18+ years
- Able to commit for the two week duration of the trial
Who cannot join
- Age <18 years
- Pregnancy
- Vegetarian
- History of allergy
- Current smoker or smoking cessation within the last 3 months
- Current use of inhaled, topical or systemic corticosteroids or within the last 2 weeks
Show all 9Show fewer
- Current use of non-steroidal anti-inflammatory use or within the last 1 week
- Current use of nutritional or multivitamin supplements
- Current participation in any other Randomised controlled trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiovascular Medicine Research Unit, Hammersmith Hospital
London, W12 0NN
About this study
Official title: Does Broccoli Sprout Consumption Result in Plasma Sulforaphane Levels That Can Attenuate Leukocyte Activation Ex-vivo in Healthy Human Volunteers?
The investigators suggest that inducing anti-oxidant enzymes indirectly may be an effective means of providing vascular protection.
Sulforaphane, a naturally occurring compound found in green vegetables (including broccoli, brussel sprouts and cauliflower) is able to protect against cell inflammatory stress by inducing a number of anti-oxidant molecules. Targeted studies on the consumption of broccoli and related vegetables have been shown to be associated with reduced risk of coronary artery disease.
In the present study the investigators want to test whether the consumption of a "broccoli smoothie" containing sulforaphane can protect white blood cells from becoming activated in the presence of an experimental stress and how long this protective effect lasts for. To do this, the investigators will be analysing inflammatory changes in blood samples taken at different times during the study.
Read the detailed description
Atherosclerosis is the disease process that leads to hardening of the arteries which causes them to become narrowed. This occurs because fat is first deposited on the inside walls of the arteries, then becomes hardened by fibrous tissue and calcium deposition forming a semi-hardened accumulation of material known as plaque. As this plaque grows, it narrows the channel within the artery and causes a reduction in blood and oxygen supply to the affected organ - such as the heart and brain. The investigators now understand that this process is caused by inflammation and activation of the immune cells over a period of time. It has been proposed that targeting these immune cells and reducing the levels of immune activation can protect against cardiovascular diseases.
Previously it has been observed that consumption of fruit and vegetables rich in anti-oxidants can confer a protective effect against cardiovascular diseases. The use of anti-oxidants experimentally has shown protective benefits against activation.
- Conditions
- Healthy Volunteers
- Being tested
- Brocco-sprout homogenate, Alfalfa sprout homogenate
- Keywords
- white blood cell, broccoli, P38 Map Kinase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brocco-sprout homogenateDietary supplement
Participants will be asked to orally consume on three consecutive days a brocco-sprout homogenate (70g dry weight).
Alfalfa sprout homogenateDietary supplement
Participants will be asked to orally consume on three consecutive days an alfalfa sprout homogenate.
| Study group | Role | What they receive |
|---|---|---|
| Brocco-sprout homogenate | Active comparator | Not described Receives: Dietary Supplement: Brocco-sprout homogenate |
| Alfalfa sprout homogenate | Sham comparator | Not described Receives: Dietary Supplement: Alfalfa sprout homogenate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resistance of leucocytes to inflammatory activation following an experimental stress
Participants will consume a brocco-sprout homogenate. Blood will be sampled for intracellular markers of leukocyte stress after ex-vivo stimulus with Phorbol ester / Tumour Necrosis Factor alpha. The following parameters will be recorded.
- Reactive oxygen species detection using aminophenylfluoresceine dye
- p38 MAP kinase induction
- NF-kB induction
Measured: 24 hours after consumption of the third homogenate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul C Evans, BSc MSc PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357070
- Sponsor's protocol ID
- 2-bao
- Status last verified
- Jul 2019
- First submitted
- 17 May 2011
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Broccoli Sprout Consumption Result in Plasma Sulforaphane Levels That Can Attenuate Leukocyte Activation Ex-vivo in Healthy Human Volunteers?
- ClinicalTrials.gov ID
- NCT01357070
- Acronym / sponsor ID
- 2-bao
- Conditions
- Healthy Volunteers
- Keywords
- white blood cell, broccoli, P38 Map Kinase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 May 2011 (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.
The investigators suggest that inducing anti-oxidant enzymes indirectly may be an effective means of providing vascular protection.
Sulforaphane, a naturally occurring compound found in green vegetables (including broccoli, brussel sprouts and cauliflower) is able to protect against cell inflammatory stress by inducing a number of anti-oxidant molecules. Targeted studies on the consumption of broccoli and related vegetables have been shown to be associated with reduced risk of coronary artery disease.
In the present study the investigators want to test whether the consumption of a "broccoli smoothie" containing sulforaphane can protect white blood cells from becoming activated in the presence of an experimental stress and how long this protective effect lasts for. To do this, the investigators will be analysing inflammatory changes in blood samples taken at different times during the study.
Detailed description
Atherosclerosis is the disease process that leads to hardening of the arteries which causes them to become narrowed. This occurs because fat is first deposited on the inside walls of the arteries, then becomes hardened by fibrous tissue and calcium deposition forming a semi-hardened accumulation of material known as plaque. As this plaque grows, it narrows the channel within the artery and causes a reduction in blood and oxygen supply to the affected organ - such as the heart and brain. The investigators now understand that this process is caused by inflammation and activation of the immune cells over a period of time. It has been proposed that targeting these immune cells and reducing the levels of immune activation can protect against cardiovascular diseases.
Previously it has been observed that consumption of fruit and vegetables rich in anti-oxidants can confer a protective effect against cardiovascular diseases. The use of anti-oxidants experimentally has shown protective benefits against activation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brocco-sprout homogenate | Active comparator | Dietary Supplement: Brocco-sprout homogenate |
| Alfalfa sprout homogenate | Sham comparator | Dietary Supplement: Alfalfa sprout homogenate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18+ years
- Able to commit for the two week duration of the trial
Key exclusion criteria (9 listed)
- Age <18 years
- Pregnancy
- Vegetarian
- History of allergy
- Current smoker or smoking cessation within the last 3 months
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 |
|---|---|---|
| Brocco-sprout homogenateParticipants will be asked to orally consume on three consecutive days a brocco-sprout homogenate (70g dry weight). | Dietary supplement | Brocco-sprout homogenate |
| Alfalfa sprout homogenateParticipants will be asked to orally consume on three consecutive days an alfalfa sprout homogenate. | Dietary supplement | Alfalfa sprout homogenate |
Primary outcome
Resistance of leucocytes to inflammatory activation following an experimental stress
Time frame: 24 hours after consumption of the third homogenate
Participants will consume a brocco-sprout homogenate. Blood will be sampled for intracellular markers of leukocyte stress after ex-vivo stimulus with Phorbol ester / Tumour Necrosis Factor alpha. The following parameters will be recorded. 1. Reactive oxygen species detection using aminophenylfluoresceine dye 2. p38 MAP kinase induction 3. NF-kB induction
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 8 Jul 2019.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Paul C Evans, BSc MSc PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brocco-sprout homogenate and Alfalfa sprout homogenate in people with Healthy Volunteers, run by Imperial College London 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 2 inclusion and 9 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 8 Jul 2019. 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. 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?
Resistance of leucocytes to inflammatory activation following an experimental stress (time frame: 24 hours after consumption of the third homogenate). 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 8 Jul 2019.