NCT02300324

Brief Summary

There is current evidence that suggests eating cruciferous vegetables like broccoli, cauliflower, cabbage is beneficial to our health as they contain compounds which are thought to reduce the risk of diseases such as cancer and cardiovascular diseases. Cruciferous vegetables are able to deliver in our body a group of compounds called isothiocyanates (ITCs) that are thought to be responsible of their health-promoting effects. Sulforaphane (SF) from broccoli is one of the most studied ITCs and its anticancer properties have been extensively investigated in in vitro and in vivo models. The investigators propose to undertake an intervention study to measure the bioavailability of SF from the soups used in another intervention study called ESCAPE. The investigators would like to investigate the rate and extent to which SF reaches the systemic circulation and is excreted in urine by measuring SF and its metabolites in plasma and urine samples collected from apparently healthy participants after consumption of the three types of broccoli + stilton soups. The three types of soups are standard broccoli + stilton soups and two high-glucoraphanin (SF precursor) broccoli + stilton soups which are able to deliver different levels of SF. This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC) and Prostate Cancer foundation (PCF).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

10 months

First QC Date

November 20, 2014

Last Update Submit

September 16, 2015

Conditions

Healthy

Keywords

bioavailabilityBenefortesulforaphane

Outcome Measures

Primary Outcomes (1)

  • Total excretion of SF in 24 hour urine samples

    To measure the total excretion of SF in urine collected for 24 hours after consumption of one pot (300g) of three types of broccoli + stilton soup containing different concentrations of glucoraphanin, SF precursor.

    0, 0-2, 2-4, 4-6, 6-8, 8-24 hours

Secondary Outcomes (1)

  • Plasma concentration of SF and its metabolites

    0, 30, 45, 60, 90, 120, 180, 240, 360, 480 mins and 24 hours

Study Arms (1)

Standard v Beneforte v Beneforte Extra

EXPERIMENTAL

This is a randomized, double-blinded, three-phase crossover trial investigating the bioavailability of SF following consumption of three types of broccoli + stilton soup containing different concentrations of glucoraphanin. The three types of soup are standard broccoli and stilton soup, beneforte broccoli and stilton soup, and beneforte extra broccoli and stilton soup.

Dietary Supplement: Standard broccoli and stilton soupDietary Supplement: Beneforte broccoli and stilton soupDietary Supplement: Beneforte Extra broccoli and stilton soup

Interventions

Standard broccoli and stilton soupDIETARY_SUPPLEMENT

Participants will be randomised to eat one portion (300g) of broccoli soup for each phase.

Standard v Beneforte v Beneforte Extra
Beneforte broccoli and stilton soupDIETARY_SUPPLEMENT

Participants will be randomised to eat one portion (300g) of broccoli soup for each phase.

Standard v Beneforte v Beneforte Extra
Beneforte Extra broccoli and stilton soupDIETARY_SUPPLEMENT

Participants will be randomised to eat one portion (300g) of broccoli soup for each phase.

Standard v Beneforte v Beneforte Extra

Eligibility Criteria

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

You may qualify if:

  • Men and women
  • Aged 18-65 years
  • Non-smokers
  • Those that live within 40 miles of IFR
  • Those who like broccoli + stilton soups

You may not qualify if:

  • Those unwilling/unable to provide urine and blood samples
  • Results of the clinical screening indicate, or are judged by the HNU medical advisor to be indicative of a health problem which could compromise the well-being of the participants if they participated, or which would affect the study outcome.
  • Those whose vein status is assessed by HNU senior research nurse as unsuitable for cannulation
  • Known history of fainting when blood samples are taken, feel unwell or faint during any clinical study day procedures at the HNU
  • Women who are or have been pregnant within the last 12 months or who are breast feeding.
  • Those diagnosed with any long-term medical condition (e.g. diabetes, haemophilia, cardiovascular disease, glaucoma, anaemia) or requiring medication that may affect the study outcome.
  • Smokers
  • Those taking dietary supplements or herbal remedies which may affect the study outcome - unless the participant is willing to discontinue taking them for 1 month prior to starting study. Please note that some supplements may not affect the study and this will be assessed on an individual basis
  • Those allergic to any of the ingredients in broccoli + stilton soups
  • Participants allergic to members of the Brassica family, e.g. mustard allergy (often combined with sensitivity to mugwort pollen, cabbage and peach) or to Brassica pollens (mustard or rapeseed).
  • Those taking any prescribed or non-prescribed medication (short or long term), which may affect the study data or participant's wellbeing. This will be assessed by the HNU medical advisor on an individual basis.
  • Those on an anti-coagulant therapy or have had anti-coagulant therapy in the past 3 months.
  • Parallel participation in another research project that involves dietary intervention
  • Any person related to or living with any member of the study team
  • Participation in another research project, which involves blood sampling within the last four months unless total blood from both studies does not exceed 470mL (unless the participants are willing to wait 4 months and then be re-screened).
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Food Research

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Related Publications (1)

  • Sivapalan T, Melchini A, Saha S, Needs PW, Traka MH, Tapp H, Dainty JR, Mithen RF. Bioavailability of Glucoraphanin and Sulforaphane from High-Glucoraphanin Broccoli. Mol Nutr Food Res. 2018 Sep;62(18):e1700911. doi: 10.1002/mnfr.201700911. Epub 2018 Mar 8.

    PMID: 29266773DERIVED

Study Officials

  • Richard Mithen, PhD

    Quadram Institute Bioscience

    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

November 20, 2014

First Posted

November 25, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 17, 2015

Record last verified: 2015-09

Locations

GB(1)