NCT01357070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

2.7 years

First QC Date

May 17, 2011

Last Update Submit

July 4, 2019

Conditions

Keywords

white blood cellbroccoliP38 Map Kinase

Outcome Measures

Primary Outcomes (1)

  • 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. 1. Reactive oxygen species detection using aminophenylfluoresceine dye 2. p38 MAP kinase induction 3. NF-kB induction

    24 hours after consumption of the third homogenate

Study Arms (2)

Brocco-sprout homogenate

ACTIVE COMPARATOR
Dietary Supplement: Brocco-sprout homogenate

Alfalfa sprout homogenate

SHAM COMPARATOR
Dietary Supplement: Alfalfa sprout homogenate

Interventions

Brocco-sprout homogenateDIETARY_SUPPLEMENT

Participants will be asked to orally consume on three consecutive days a brocco-sprout homogenate (70g dry weight).

Brocco-sprout homogenate
Alfalfa sprout homogenateDIETARY_SUPPLEMENT

Participants will be asked to orally consume on three consecutive days an alfalfa sprout homogenate.

Alfalfa sprout homogenate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18+ years
  • Able to commit for the two week duration of the trial

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Medicine Research Unit, Hammersmith Hospital

London, W12 0NN, United Kingdom

Location

Study Officials

  • Paul C Evans, BSc MSc PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 20, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Clinical Study Report (DOI:10.4172/2472-1921.100060)Access

Locations