ADaPT: Accumulation of Dietary Bioactives and Prostate Cancer

• Sponsor: Quadram Institute Bioscience (Other)
• Overall Status: Completed
• CT.gov ID: NCT04046653
• Collaborator: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK) (Other)
• Enrollment: 40
• Location: 1
• Arms: 4
• Actual Duration (Months): 6.3
• Patients Per Site Per Month: 6.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Dietary Supplement: Allin; Dietary Supplement: Sulforaphane; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jul 3, 2019
• Actual Primary Completion Date: Jan 12, 2020
• Actual Study Completion Date: Jan 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study arm 1 Allin capsules (x2) and Sulforaphane capsules (x2) once daily for 4 weeks	Dietary Supplement: Allin; Dietary supplement; Dietary Supplement: Sulforaphane; Dietary supplement
Experimental: Study arm 2 Allin capsules (x2) and placebo capsules (x2) once daily for 4 weeks	Dietary Supplement: Allin; Dietary supplement; Dietary Supplement: Placebo; Dietary supplement
Experimental: Study arm 3 Sulforaphane capsules (x2) and placebo capsules (x2) once daily for 4 weeks	Dietary Supplement: Sulforaphane; Dietary supplement; Dietary Supplement: Placebo; Dietary supplement
Placebo Comparator: Study arm 4 Placebo capsules (x4) once daily for 4 weeks	Dietary Supplement: Placebo; Dietary supplement

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quadram Institute Bioscience	Norwich	Norfolk	United Kingdom	NR4 7UQ

Sponsors and Collaborators

• Quadram Institute Bioscience
• Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Investigators

• Principal Investigator: Richard Mithen, pHD, Quadram Institute Bioscience
• Principal Investigator: Robert Mills, Dr, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Quadram Institute Bioscience
• ClinicalTrials.gov Identifier: NCT04046653
• Other Study ID Numbers: QIB01/2019
• First Posted: Aug 6, 2019
• Last Update Posted: Nov 18, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms; Sulforaphane

Study Results

No Results Posted as of Nov 18, 2020