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Completed

NCT Number: NCT04046653

Accumulation of Dietary Bioactives and Prostate Cancer

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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Quadram Institute Bioscience

Norwich, Norfolk, NR4 7UQ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Allin

Dietary Supplement

Dietary supplement

Sulforaphane

Dietary Supplement

Dietary supplement

Placebo

Dietary Supplement

Dietary supplement

Primary outcomes

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

    Time frame: 4 Weeks

    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

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

    Time frame: 4 weeks

    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

  2. Urinary excretion of Sulforaphane and Alliin metabolites

    Time frame: 24-hours

    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

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

    Time frame: 4 weeks

    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

  4. Microbiome profile

    Time frame: 4 weeks

    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

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

    Time frame: After 4 weeks

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

Sponsors and collaborators

Lead sponsor

Quadram Institute Bioscience

Other

Collaborators

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

Registry information

Official study title

A Pre-biopsy Window of Opportunity Trial to Measure the Dietary Bioactive Levels in the Prostate Following an Intervention With Sulforaphane and Allin Dietary Supplements

Acronym: ADaPT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2019
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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