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Accumulation of Dietary Bioactives and Prostate Cancer (ADaPT)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Allin
Sulforaphane
Placebo
Sponsored by
Quadram Institute Bioscience
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Quadram Institute Bioscience

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Study arm 1

Study arm 2

Study arm 3

Study arm 4

Arm Description

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

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

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

Placebo capsules (x4) once daily for 4 weeks

Outcomes

Primary Outcome Measures

Concentration of sulforaphane, alliin and their metabolites in prostate tissue as measured by mass spectrometry
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

Secondary Outcome Measures

2. Concentration of sulforaphane, alliin and their metabolites in in the transitional and peripheral zones of the prostate as measured by mass spectrometry
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
Urinary excretion of Sulforaphane and Alliin metabolites
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
4. Changes in global gene expression in prostate tissue as measured using next generation sequencing
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
Microbiome profile
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
Number of participants with glutathione S-transferase M1 (GSTM1) genotype null and positive
Changes in sulforaphane and alliin metabolites associated with Glutathione S-transferase M1 polymorphism (GSTM1 genotype)

Full Information

First Posted
July 17, 2019
Last Updated
November 17, 2020
Sponsor
Quadram Institute Bioscience
Collaborators
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
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1. Study Identification

Unique Protocol Identification Number
NCT04046653
Brief Title
Accumulation of Dietary Bioactives and Prostate Cancer
Acronym
ADaPT
Official Title
A Pre-biopsy Window of Opportunity Trial to Measure the Dietary Bioactive Levels in the Prostate Following an Intervention With Sulforaphane and Allin Dietary Supplements
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
January 12, 2020 (Actual)
Study Completion Date
January 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Quadram Institute Bioscience
Collaborators
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study arm 1
Arm Type
Experimental
Arm Description
Allin capsules (x2) and Sulforaphane capsules (x2) once daily for 4 weeks
Arm Title
Study arm 2
Arm Type
Experimental
Arm Description
Allin capsules (x2) and placebo capsules (x2) once daily for 4 weeks
Arm Title
Study arm 3
Arm Type
Experimental
Arm Description
Sulforaphane capsules (x2) and placebo capsules (x2) once daily for 4 weeks
Arm Title
Study arm 4
Arm Type
Placebo Comparator
Arm Description
Placebo capsules (x4) once daily for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Allin
Intervention Description
Dietary supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Sulforaphane
Intervention Description
Dietary supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Dietary supplement
Primary Outcome Measure Information:
Title
Concentration of sulforaphane, alliin and their metabolites in prostate tissue as measured by mass spectrometry
Description
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
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
2. Concentration of sulforaphane, alliin and their metabolites in in the transitional and peripheral zones of the prostate as measured by mass spectrometry
Description
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
Time Frame
4 weeks
Title
Urinary excretion of Sulforaphane and Alliin metabolites
Description
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
Time Frame
24-hours
Title
4. Changes in global gene expression in prostate tissue as measured using next generation sequencing
Description
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
Time Frame
4 weeks
Title
Microbiome profile
Description
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
Time Frame
4 weeks
Title
Number of participants with glutathione S-transferase M1 (GSTM1) genotype null and positive
Description
Changes in sulforaphane and alliin metabolites associated with Glutathione S-transferase M1 polymorphism (GSTM1 genotype)
Time Frame
After 4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Mithen, pHD
Organizational Affiliation
Quadram Institute Bioscience
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Mills, Dr
Organizational Affiliation
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quadram Institute Bioscience
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Accumulation of Dietary Bioactives and Prostate Cancer

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