- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01357070
Effect of Broccoli Sprout on Blood Levels of Sulforaphane to Reduce Responsiveness of Immune System
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London, United Kingdom, W12 0NN
- Cardiovascular Medicine Research Unit, Hammersmith Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18+ years
- Able to commit for the two week duration of the trial
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: Brocco-sprout homogenate
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Participants will be asked to orally consume on three consecutive days a brocco-sprout homogenate (70g dry weight).
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SHAM_COMPARATOR: Alfalfa sprout homogenate
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Participants will be asked to orally consume on three consecutive days an alfalfa sprout homogenate.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
24 hours after consumption of the third homogenate
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul C Evans, BSc MSc PhD, Imperial College London
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2-bao
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
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Clinical Study Report
Information identifier: DOI:10.4172/2472-1921.100060Information comments: RESULTS REPORT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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