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Effect of Broccoli Sprout on Blood Levels of Sulforaphane to Reduce Responsiveness of Immune System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01357070
Recruitment Status : Completed
First Posted : May 20, 2011
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
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Brief 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 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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Dietary Supplement: Brocco-sprout homogenate Dietary Supplement: Alfalfa sprout homogenate Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Does Broccoli Sprout Consumption Result in Plasma Sulforaphane Levels That Can Attenuate Leukocyte Activation Ex-vivo in Healthy Human Volunteers?
Study Start Date : May 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Alfalfa

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Brocco-sprout homogenate Dietary Supplement: Brocco-sprout homogenate
Participants will be asked to orally consume on three consecutive days a brocco-sprout homogenate (70g dry weight).
Sham Comparator: Alfalfa sprout homogenate Dietary Supplement: Alfalfa sprout homogenate
Participants will be asked to orally consume on three consecutive days an alfalfa sprout homogenate.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357070


Locations
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United Kingdom
Cardiovascular Medicine Research Unit, Hammersmith Hospital
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Paul C Evans, BSc MSc PhD Imperial College London
More Information
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Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: DOI:10.4172/2472-1921.100060
RESULTS REPORT

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01357070    
Other Study ID Numbers: 2-bao
First Posted: May 20, 2011    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
white blood cell
broccoli
P38 Map Kinase