Accumulation of Dietary Bioactives and Prostate Cancer (ADaPT)

Quadram Institute Bioscience

Status: Completed

Conditions: Prostate Cancer

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Allin; Dietary Supplement: Sulforaphane

Study type: Interventional

Funder types: Other

Identifiers

NCT04046653

QIB01/2019

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

Study arm 1

Experimental group

Description:

Allin capsules (x2) and Sulforaphane capsules (x2) once daily for 4 weeks

Treatment:

Dietary Supplement: Allin

Dietary Supplement: Sulforaphane

Study arm 2

Experimental group

Description:

Allin capsules (x2) and placebo capsules (x2) once daily for 4 weeks

Treatment:

Dietary Supplement: Allin

Dietary Supplement: Placebo

Study arm 3

Experimental group

Description:

Sulforaphane capsules (x2) and placebo capsules (x2) once daily for 4 weeks

Treatment:

Dietary Supplement: Sulforaphane

Dietary Supplement: Placebo

Study arm 4

Placebo Comparator group

Description:

Placebo capsules (x4) once daily for 4 weeks

Treatment:

Dietary Supplement: Placebo