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

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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

Tracking Information
First Submitted Date  ICMJE May 17, 2011
First Posted Date  ICMJE May 20, 2011
Last Update Posted Date July 8, 2019
Study Start Date  ICMJE May 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01357070 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Broccoli Sprout on Blood Levels of Sulforaphane to Reduce Responsiveness of Immune System
Official Title  ICMJE Does Broccoli Sprout Consumption Result in Plasma Sulforaphane Levels That Can Attenuate Leukocyte Activation Ex-vivo in Healthy Human Volunteers?
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Dietary Supplement: Brocco-sprout homogenate
    Participants will be asked to orally consume on three consecutive days a brocco-sprout homogenate (70g dry weight).
  • Dietary Supplement: Alfalfa sprout homogenate
    Participants will be asked to orally consume on three consecutive days an alfalfa sprout homogenate.
Study Arms  ICMJE
  • Active Comparator: Brocco-sprout homogenate
    Intervention: Dietary Supplement: Brocco-sprout homogenate
  • Sham Comparator: Alfalfa sprout homogenate
    Intervention: Dietary Supplement: Alfalfa sprout homogenate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2011)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01357070
Other Study ID Numbers  ICMJE 2-bao
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul C Evans, BSc MSc PhD Imperial College London
PRS Account Imperial College London
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP