Accumulation of Dietary Bioactives and Prostate Cancer

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EstadoActivo, no reclutando

Patrocinadores

Quadram Institute Bioscience

Colaboradores

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

ENSAYO CLÍNICO: NCT04046653

BioSeek: nct04046653

Palabras clave

Abstracto

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.

fechas

Verificado por última vez:	05/31/2020
Primero enviado:	07/16/2019
Inscripción estimada enviada:	08/01/2019
Publicado por primera vez:	08/05/2019
Última actualización enviada:	06/16/2020
Última actualización publicada:	06/17/2020
Fecha de inicio real del estudio:	07/02/2019
Fecha estimada de finalización primaria:	07/31/2020
Fecha estimada de finalización del estudio:	07/31/2020

Condición o enfermedad

Prostate Cancer

Intervención / tratamiento

Dietary Supplement: Allin

Dietary Supplement: Sulforaphane

Dietary Supplement: Placebo

Fase

Grupos de brazos

Brazo	Intervención / tratamiento
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

Criterio de elegibilidad

Edades elegibles para estudiar	18 Years A 18 Years
Sexos elegibles para estudiar	Male
Acepta voluntarios saludables	si
Criterios	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.

Salir

Medidas de resultado primarias

1. 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

Medidas de resultado secundarias

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]

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 [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 [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 [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 [After 4 weeks]

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