NCT02821728

Brief Summary

This study evaluates whether a broccoli intervention (≥ 4 weeks) will result in differences in tissue sulphate levels in men scheduled for prostate biopsies. Comparisons will be made between participants randomised to the broccoli-rich diet and those randomised to the non-intervention arm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable prostate-cancer

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

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 2, 2017

Status Verified

June 1, 2017

Enrollment Period

8 months

First QC Date

June 21, 2016

Last Update Submit

June 1, 2017

Conditions

Prostate Cancer

Keywords

ProstateSulphateATPPTEN

Outcome Measures

Primary Outcomes (1)

  • Sulphate level

    Sulphate levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.

    Biopsy on a single occasion at ≥ 4 weeks

Secondary Outcomes (2)

  • ADP

    Biopsy on a single occasion at ≥ 4 weeks

  • Redox status of phosphatase proteins

    Biopsy on a single occasion at ≥ 4 weeks

Study Arms (2)

Normal diet

EXPERIMENTAL

No dietary intervention

Other: Normal diet

Dietary intervention

EXPERIMENTAL

3 portions of broccoli soup per week

Dietary Supplement: Dietary intervention

Interventions

Dietary interventionDIETARY_SUPPLEMENT

Participants in this group will consume three portions of broccoli and stilton soup per week for a minimum of four weeks before their scheduled template prostate biopsy. The soup will be made with a specially cultivated broccoli known as Beneforte, which contains an enhanced dose of a substance called glucoraphanin.

Dietary intervention
Normal dietOTHER

Participants in this group will continue with their normal diet up until the day of their scheduled template prostate biopsy.

Normal diet

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males
  • Scheduled for TPB as part of routine investigation or staging for prostate cancer
  • Aged 18-80 years
  • BMI between 19.5 and 35 kg/m2
  • Smokers and non-smokers

You may not qualify if:

  • Those regularly taking 5α-reductase inhibitors or testosterone replacement medicines
  • Those on warfarin treatment
  • Those diagnosed with diabetes
  • Those diagnosed with or suspected to be high-risk for human immunodeficiency virus (HIV) and/or hepatitis
  • Those allergic to any of the ingredients of the broccoli soups
  • Those taking dietary supplements or herbal remedies which may affect the study outcome. Please note that some supplements may not affect the study and this will be assessed on an individual basis
  • Those that are unable to understand English or give informed consent
  • Parallel participation in another research project that involves dietary intervention
  • Any person related to or living with any member of the study team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Related Publications (1)

  • Coode-Bate J, Sivapalan T, Melchini A, Saha S, Needs PW, Dainty JR, Maicha JB, Beasy G, Traka MH, Mills RD, Ball RY, Mithen RF. Accumulation of Dietary S-Methyl Cysteine Sulfoxide in Human Prostate Tissue. Mol Nutr Food Res. 2019 Oct;63(20):e1900461. doi: 10.1002/mnfr.201900461. Epub 2019 Sep 11.

    PMID: 31410992DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Richard Mithen, PhD

    Quadram Institute Bioscience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

July 4, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2016

Study Completion

April 1, 2017

Last Updated

June 2, 2017

Record last verified: 2017-06

Locations

GB(1)