Accumulation of Dietary Bioactives and Prostate Cancer

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Пријави се / Пријави се

Веза се чува у привремену меморију

СтатусАктиван, не регрутује

Спонзори

Quadram Institute Bioscience

Сарадници

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

КЛИНИЧКО ИСПИТИВАЊЕ: NCT04046653

BioSeek: nct04046653

Кључне речи

Апстрактан

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.

Датуми

Последња верификација:	05/31/2020
Фирст Субмиттед:	07/16/2019
Предвиђена пријава послата:	08/01/2019
Прво објављено:	08/05/2019
Послато последње ажурирање:	06/16/2020
Последње ажурирање објављено:	06/17/2020
Стварни датум почетка студије:	07/02/2019
Процењени датум примарног завршетка:	07/31/2020
Предвиђени датум завршетка студије:	07/31/2020

Стање или болест

Prostate Cancer

Интервенција / лечење

Dietary Supplement: Allin

Dietary Supplement: Sulforaphane

Dietary Supplement: Placebo

Фаза

Групе руку

Арм	Интервенција / лечење
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

Критеријуми

Узраст подобан за студирање	18 Years До 18 Years
Полови подобни за студирање	Male
Прихвата здраве волонтере	да
Критеријуми	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.

Исход

Примарне мере исхода

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

Секундарне мере исхода

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)