Accumulation of Dietary Bioactives and Prostate Cancer

Prostate Cancer Clinical Trial

— ADaPT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04046653
• Other study ID #: QIB01/2019
• Status: Completed
• Phase: N/A
• Start date: July 3, 2019
• Est. completion date: January 12, 2020

Study information

• Verified date: November 2020
• Source: Quadram Institute Bioscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 12, 2020
• Est. primary completion date: January 12, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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 5a-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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• Allin
Dietary supplement
• Sulforaphane
Dietary supplement
• Placebo
Dietary supplement

Locations

Country	Name	City	State
United Kingdom	Quadram Institute Bioscience	Norwich	Norfolk

Sponsors (2)

Lead Sponsor	Collaborator
Quadram Institute Bioscience	Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	4 weeks
Secondary	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	24-hours
Secondary	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	4 weeks
Secondary	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	4 weeks
Secondary	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)	After 4 weeks