Accumulation of Dietary Bioactives and Prostate Cancer

NCT ID: NCT04046653

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-03

Study Completion Date

2020-01-12

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Study arm 1

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

Group Type EXPERIMENTAL

Allin

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement

Sulforaphane

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement

Study arm 2

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

Group Type EXPERIMENTAL

Allin

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement

Placebo

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement

Study arm 3

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

Group Type EXPERIMENTAL

Sulforaphane

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement

Placebo

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement

Study arm 4

Placebo capsules (x4) once daily for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement

Interventions

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Allin

Dietary supplement

Intervention Type DIETARY_SUPPLEMENT

Sulforaphane

Dietary supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo

Dietary supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role collaborator

Quadram Institute Bioscience

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Mithen, pHD

Role: PRINCIPAL_INVESTIGATOR

Quadram Institute Bioscience

Robert Mills, Dr

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Quadram Institute Bioscience

Norwich, Norfolk, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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QIB01/2019

Identifier Type: -

Identifier Source: org_study_id