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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01357070
First received: May 17, 2011
Last updated: May 19, 2011
Last verified: May 2011
  Purpose

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. 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 Intervention
Healthy Volunteers
Dietary Supplement: Brocco-sprout homogenate
Dietary Supplement: Alfalfa sprout homogenate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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?

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Resistance of leucocytes to inflammatory activation following an experimental stress [ Time Frame: 24 hours after consumption of the third homogenate ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 6
Study Start Date: May 2011
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357070

Contacts
Contact: Bao AV Nguyen, MSc MRCS 02083833064 bao.nguyen07@imperial.ac.uk

Locations
United Kingdom
Cardiovascular Medicine Research Unit, Hammersmith Hospital Recruiting
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Paul C Evans, BSc MSc PhD Imperial College London
  More Information

No publications provided

Responsible Party: Dr Paul Evans/Reader in Endothelial Physiology, Imperial College London
ClinicalTrials.gov Identifier: NCT01357070     History of Changes
Other Study ID Numbers: 2-bao
Study First Received: May 17, 2011
Last Updated: May 19, 2011
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on November 25, 2014