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CompletedNCT04046653ADaPTUpdated Nov 18, 2020

Accumulation of Dietary Bioactives and Prostate Cancer

An interventional study of Allin and Sulforaphane in Prostate Cancer, sponsored by Quadram Institute Bioscience. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-18.

Sponsored by Quadram Institute Bioscience · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Male
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Study 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.

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Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 40 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Quadram Institute Bioscience is the lead sponsor of 42 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Study arm 1

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

    Dietary Supplement: Allin · Dietary Supplement: Sulforaphane

  • Experimental
    Study arm 2

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

    Dietary Supplement: Allin · Dietary Supplement: Placebo

  • Experimental
    Study arm 3

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

    Dietary Supplement: Sulforaphane · Dietary Supplement: Placebo

  • Placebo comparator
    Study arm 4

    Placebo capsules (x4) once daily for 4 weeks

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementAllin

    Dietary supplement

  • Dietary supplementSulforaphane

    Dietary supplement

  • Dietary supplementPlacebo

    Dietary supplement

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What researchers measure

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

    Time frame: 4 Weeks

Secondary outcomes

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

    Treatment-related differences in spatial accumulation of Sulforaphane and Alliin, or their human and microbial metabolites, in the transitional and peripheral zones of the prostate compared with placebo following a 4-week period of supplementation

    Time frame: 4 weeks

  2. Urinary excretion of Sulforaphane and Alliin metabolites

    Treatment-related differences in the urinary excretion levels of Sulforaphane and Alliin, or their human and microbial metabolites, following the initial 24-h period of supplementation

    Time frame: 24-hours

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

    Treatment-related differences in global gene expression in the prostate tissue, following a 4-week period of supplementation with Sulforaphane and Alliin, compared with placebo

    Time frame: 4 weeks

  4. Microbiome profile

    Treatment-related differences in prostatic tissue microbiome from the peripheral and transitional zones, following a 4-week period of supplementation with Sulforaphane and Alliin compared with placebo

    Time frame: 4 weeks

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

    Changes in sulforaphane and alliin metabolites associated with Glutathione S-transferase M1 polymorphism (GSTM1 genotype)

    Time frame: After 4 weeks

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Study locations

1 site
  • Quadram Institute Bioscience
    Norwich, Norfolk NR4 7UQ, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04046653
Lead sponsor
Quadram Institute Bioscience
Collaborators
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Responsible party
Sponsor
First posted
Aug 6, 2019
Start date
Jul 3, 2019
Primary completion
Jan 12, 2020
Completion
Jan 12, 2020
Last update
Nov 18, 2020

Study contacts

Richard Mithen, pHD
principal investigator · Quadram Institute Bioscience
Robert Mills, Dr
principal investigator · Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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