Accumulation of Dietary Bioactives and Prostate Cancer
Nøgleord
Abstrakt
Datoer
Sidst bekræftet: | 05/31/2020 |
Først indsendt: | 07/16/2019 |
Anslået tilmelding indsendt: | 08/01/2019 |
Først indsendt: | 08/05/2019 |
Sidste opdatering indsendt: | 06/16/2020 |
Sidste opdatering indsendt: | 06/17/2020 |
Faktisk startdato for undersøgelsen: | 07/02/2019 |
Anslået primær afslutningsdato: | 07/31/2020 |
Anslået afslutningsdato for undersøgelsen: | 07/31/2020 |
Tilstand eller sygdom
Intervention / behandling
Dietary Supplement: Allin
Dietary Supplement: Sulforaphane
Dietary Supplement: Placebo
Fase
Armgrupper
Arm | Intervention / behandling |
---|---|
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 |
Kriterier for støtteberettigelse
Alder berettiget til undersøgelse | 18 Years Til 18 Years |
Køn, der er berettiget til undersøgelse | Male |
Accepterer sunde frivillige | Ja |
Kriterier | 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. |
Resultat
Primære resultatforanstaltninger
1. Concentration of sulforaphane, alliin and their metabolites in prostate tissue as measured by mass spectrometry [4 Weeks]
Sekundære resultatforanstaltninger
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]