NCT04046653

Brief Summary

Current research suggests that diets rich in multiple food types (such as broccoli, onions and garlic) are beneficial to our health and may reduce the risk of some cancers, including prostate cancer. The purpose of this study is to investigate the relationship between ingestion of the bioactive compounds from broccoli and garlic, and prostate metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Jul 2019

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

July 3, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

July 17, 2019

Last Update Submit

November 17, 2020

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Concentration of sulforaphane, alliin and their metabolites in prostate tissue as measured by mass spectrometry

    Treatment-related differences in prostatic accumulation of Sulforaphane and Alliin, or their human and microbial metabolites, compared with placebo following a 4-week period of supplementation

    4 Weeks

Secondary Outcomes (5)

  • 2. Concentration of sulforaphane, alliin and their metabolites in in the transitional and peripheral zones of the prostate as measured by mass spectrometry

    4 weeks

  • Urinary excretion of Sulforaphane and Alliin metabolites

    24-hours

  • 4. Changes in global gene expression in prostate tissue as measured using next generation sequencing

    4 weeks

  • Microbiome profile

    4 weeks

  • Number of participants with glutathione S-transferase M1 (GSTM1) genotype null and positive

    After 4 weeks

Study Arms (4)

Study arm 1

EXPERIMENTAL

Allin capsules (x2) and Sulforaphane capsules (x2) once daily for 4 weeks

Dietary Supplement: AllinDietary Supplement: Sulforaphane

Study arm 2

EXPERIMENTAL

Allin capsules (x2) and placebo capsules (x2) once daily for 4 weeks

Dietary Supplement: AllinDietary Supplement: Placebo

Study arm 3

EXPERIMENTAL

Sulforaphane capsules (x2) and placebo capsules (x2) once daily for 4 weeks

Dietary Supplement: SulforaphaneDietary Supplement: Placebo

Study arm 4

PLACEBO COMPARATOR

Placebo capsules (x4) once daily for 4 weeks

Dietary Supplement: Placebo

Interventions

AllinDIETARY_SUPPLEMENT

Dietary supplement

Study arm 1Study arm 2
SulforaphaneDIETARY_SUPPLEMENT

Dietary supplement

Study arm 1Study arm 3
PlaceboDIETARY_SUPPLEMENT

Dietary supplement

Study arm 2Study arm 3Study arm 4

Eligibility Criteria

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

You may qualify if:

  • Scheduled for template biopsy of the prostate as part of routine investigation or staging for prostate cancer at the Norfolk and Norwich University Hospital
  • 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 viral hepatitis
  • Those allergic to any of the ingredients included in the supplements (including those with lactose intolerance)
  • Those taking additional dietary supplements or herbal remedies that could affect the study outcome.
  • 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)

Quadram Institute Bioscience

Norwich, Norfolk, NR4 7UQ, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

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

Study Officials

  • Richard Mithen, pHD

    Quadram Institute Bioscience

    PRINCIPAL INVESTIGATOR

  • Robert Mills, Dr

    Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 17, 2019

First Posted

August 6, 2019

Study Start

July 3, 2019

Primary Completion

January 12, 2020

Study Completion

January 12, 2020

Last Updated

November 18, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)