Accumulation of Dietary Bioactives and Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Dietary Supplement: Allin; Dietary Supplement: Sulforaphane; Dietary Supplement: Placebo

• Registration Number: NCT04046653
• Lead Sponsor: Quadram Institute Bioscience

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-03
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-06
• Primary Completion: 2020-01-12
• Study Completion: 2020-01-12
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study arm 1	Sulforaphane	Allin capsules (x2) and Sulforaphane capsules (x2) once daily for 4 weeks
Study arm 2	Placebo	Allin capsules (x2) and placebo capsules (x2) once daily for 4 weeks
Study arm 4	Placebo	Placebo capsules (x4) once daily for 4 weeks
Study arm 1	Allin	Allin capsules (x2) and Sulforaphane capsules (x2) once daily for 4 weeks
Study arm 2	Allin	Allin capsules (x2) and placebo capsules (x2) once daily for 4 weeks
Study arm 3	Sulforaphane	Sulforaphane capsules (x2) and placebo capsules (x2) once daily for 4 weeks
Study arm 3	Placebo	Sulforaphane capsules (x2) and placebo capsules (x2) once daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Concentration of sulforaphane, alliin and their metabolites in prostate tissue as measured by mass spectrometry	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 Outcome Measures

Name	Time	Method
4. Changes in global gene expression in prostate tissue as measured using next generation sequencing	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
Number of participants with glutathione S-transferase M1 (GSTM1) genotype null and positive	After 4 weeks	Changes in sulforaphane and alliin metabolites associated with Glutathione S-transferase M1 polymorphism (GSTM1 genotype)
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	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
Urinary excretion of Sulforaphane and Alliin metabolites	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
Microbiome profile	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

Trial Locations

Locations (1)

Quadram Institute Bioscience; 🇬🇧 Norwich, Norfolk, United Kingdom