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| Name | Class |
|---|---|
| Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm 1 | Experimental | Allin capsules (x2) and Sulforaphane capsules (x2) once daily for 4 weeks |
|
| Study arm 2 | Experimental | Allin capsules (x2) and placebo capsules (x2) once daily for 4 weeks |
|
| Study arm 3 | Experimental | Sulforaphane capsules (x2) and placebo capsules (x2) once daily for 4 weeks |
|
| Study arm 4 | Placebo Comparator | Placebo capsules (x4) once daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allin | Dietary Supplement | Dietary supplement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Mithen, pHD | Quadram Institute Bioscience | Principal Investigator |
| Robert Mills, Dr | Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quadram Institute Bioscience | Norwich | Norfolk | NR4 7UQ | United Kingdom |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C016766 | sulforaphane |
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| Sulforaphane |
| Dietary Supplement |
Dietary supplement |
|
| Placebo | Dietary Supplement | Dietary supplement |
|
| 4 weeks |
| 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 | 24-hours |
| 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 | 4 weeks |
| 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 | 4 weeks |
| 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) | After 4 weeks |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |