Accumulation of Dietary Bioactives and Prostate Cancer

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Sponsoren

Quadram Institute Bioscience

Mitarbeiter

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

KLINISCHE STUDIE: NCT04046653

BioSeek: nct04046653

Schlüsselwörter

Abstrakt

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.

Termine

Zuletzt überprüft:	05/31/2020
Zuerst eingereicht:	07/16/2019
Geschätzte Einschreibung eingereicht:	08/01/2019
Zuerst veröffentlicht:	08/05/2019
Letztes eingereichtes Update:	06/16/2020
Letztes Update veröffentlicht:	06/17/2020
Tatsächliches Startdatum der Studie:	07/02/2019
Geschätztes primäres Abschlussdatum:	07/31/2020
Voraussichtliches Abschlussdatum der Studie:	07/31/2020

Zustand oder Krankheit

Prostate Cancer

Intervention / Behandlung

Dietary Supplement: Allin

Dietary Supplement: Sulforaphane

Dietary Supplement: Placebo

Phase

Armgruppen

Arm	Intervention / Behandlung
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

Zulassungskriterien

Altersberechtigt für das Studium	18 Years Zu 18 Years
Studienberechtigte Geschlechter	Male
Akzeptiert gesunde Freiwillige	Ja
Kriterien	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.

Ergebnis

Primäre Ergebnismaße

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

Sekundäre Ergebnismaße

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)