Accumulation of Dietary Bioactives and Prostate Cancer

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СтатусАктивно, не регрутирање

Спонзори

Quadram Institute Bioscience

Соработници

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

КЛИНИЧКО ИСПИТУВАЊЕ: NCT04046653

BioSeek: nct04046653

Клучни зборови

Апстракт

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

Последен пат проверено:	05/31/2020
Прво доставено:	07/16/2019
Поднесено е проценето запишување:	08/01/2019
Прво објавено:	08/05/2019
Последното ажурирање е доставено:	06/16/2020
Последно ажурирање објавено:	06/17/2020
Крај на датумот на започнување на студијата:	07/02/2019
Проценет датум на примарно завршување:	07/31/2020
Проценет датум на завршување на студијата:	07/31/2020

Состојба или болест

Prostate Cancer

Интервенција / третман

Dietary Supplement: Allin

Dietary Supplement: Sulforaphane

Dietary Supplement: Placebo

Фаза

Групи за раце

Рака	Интервенција / третман
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

Критериуми за подобност

Возраст подобни за студии	18 Years До 18 Years
Полови квалификувани за студии	Male
Прифаќа здрави волонтери	Да
Критериуми	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

Мерки на примарниот исход

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

Секундарни мерки на исходот

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)