Accumulation of Dietary Bioactives and Prostate Cancer
Keywords
Abstract
Dates
Last Verified: | 05/31/2020 |
First Submitted: | 07/16/2019 |
Estimated Enrollment Submitted: | 08/01/2019 |
First Posted: | 08/05/2019 |
Last Update Submitted: | 06/16/2020 |
Last Update Posted: | 06/17/2020 |
Actual Study Start Date: | 07/02/2019 |
Estimated Primary Completion Date: | 07/31/2020 |
Estimated Study Completion Date: | 07/31/2020 |
Condition or disease
Intervention/treatment
Dietary Supplement: Allin
Dietary Supplement: Sulforaphane
Dietary Supplement: Placebo
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: Study arm 1 Allin capsules (x2) and Sulforaphane capsules (x2) once daily for 4 weeks | |
Experimental: Study arm 2 Allin capsules (x2) and placebo capsules (x2) once daily for 4 weeks | |
Experimental: Study arm 3 Sulforaphane capsules (x2) and placebo capsules (x2) once daily for 4 weeks | |
Placebo Comparator: Study arm 4 Placebo capsules (x4) once daily for 4 weeks |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | Male |
Accepts Healthy Volunteers | Yes |
Criteria | 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. |
Outcome
Primary Outcome Measures
1. Concentration of sulforaphane, alliin and their metabolites in prostate tissue as measured by mass spectrometry [4 Weeks]
Secondary Outcome Measures
1. 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]
2. Urinary excretion of Sulforaphane and Alliin metabolites [24-hours]
3. 4. Changes in global gene expression in prostate tissue as measured using next generation sequencing [4 weeks]
4. Microbiome profile [4 weeks]
5. Number of participants with glutathione S-transferase M1 (GSTM1) genotype null and positive [After 4 weeks]