Accumulation of Dietary Bioactives and Prostate Cancer

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Rėmėjai

Quadram Institute Bioscience

Bendradarbiai

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

KLINIKINIS TYRIMAS: NCT04046653

BioSeek: nct04046653

Raktažodžiai

Santrauka

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.

Datos

Paskutinį kartą patikrinta:	05/31/2020
Pirmasis pateikimas:	07/16/2019
Numatytas registravimas pateiktas:	08/01/2019
Pirmas paskelbtas:	08/05/2019
Paskutinis atnaujinimas pateiktas:	06/16/2020
Paskutinis atnaujinimas paskelbtas:	06/17/2020
Faktinė studijų pradžios data:	07/02/2019
Numatoma pirminio užbaigimo data:	07/31/2020
Numatoma studijų užbaigimo data:	07/31/2020

Būklė ar liga

Prostate Cancer

Intervencija / gydymas

Dietary Supplement: Allin

Dietary Supplement: Sulforaphane

Dietary Supplement: Placebo

Fazė

Rankų grupės

Ranka	Intervencija / gydymas
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

Tinkamumo kriterijai

Amžius, tinkami studijuoti	18 Years Į 18 Years
Tinkamos studijoms lytys	Male
Priima sveikus savanorius	Taip
Kriterijai	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.

Rezultatas

Pirminės rezultatų priemonės

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

Antrinės rezultatų priemonės

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)