Sulphate Accumulation in Prostate

NCT ID: NCT02821728

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-04-30

Brief Summary

This study evaluates whether a broccoli intervention (≥ 4 weeks) will result in differences in tissue sulphate levels in men scheduled for prostate biopsies. Comparisons will be made between participants randomised to the broccoli-rich diet and those randomised to the non-intervention arm.

Detailed Description

Epidemiological studies provide evidence for a negative correlation between prostate cancer and intake of cruciferous vegetables such as broccoli. Preliminary data from ongoing intervention trials carried out at the IFR suggest that dietary changes can directly influence the metabolic profile of prostate tissue. The most significant result observed to date is that of sulphate accumulation within the prostate. The additional sulphate is likely to drive synthesis of 3'-phosphoadenosine-5'-phosphosulfate, a universal sulphate donor, a process which would consume energy from ATP. A significant rise in levels of both ADP and phosphate has also been observed in prostate tissue from these studies, supporting the potential depletion of cellular ATP. Interestingly, the data indicate that the extent of ADP accumulation is negatively correlated with prostate cancer progression.

The investigators now propose to undertake a two arm parallel un-blinded study to test the hypothesis that a short-term intervention with broccoli soups will lead to the accumulation of sulphate and ADP in prostate tissue. A potential increase in glutathione metabolites indicating a change in redox status, and therefore functional status, of specific genes involved in tumour suppression (PTEN) will also be investigated.

Furthermore, the investigators aim to determine whether the accumulation of sulphate and ADP is specific to the prostate gland through the metabolic analyses of both prostate and non-prostate tissues.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Normal diet

No dietary intervention

Group Type: EXPERIMENTAL

Normal diet

Intervention Type: OTHER

Participants in this group will continue with their normal diet up until the day of their scheduled template prostate biopsy.

Dietary intervention

3 portions of broccoli soup per week

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: DIETARY_SUPPLEMENT

Participants in this group will consume three portions of broccoli and stilton soup per week for a minimum of four weeks before their scheduled template prostate biopsy. The soup will be made with a specially cultivated broccoli known as Beneforte, which contains an enhanced dose of a substance called glucoraphanin.

Interventions

Dietary intervention

Participants in this group will consume three portions of broccoli and stilton soup per week for a minimum of four weeks before their scheduled template prostate biopsy. The soup will be made with a specially cultivated broccoli known as Beneforte, which contains an enhanced dose of a substance called glucoraphanin.

Intervention Type: DIETARY_SUPPLEMENT

Normal diet

Participants in this group will continue with their normal diet up until the day of their scheduled template prostate biopsy.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Males
• Scheduled for TPB as part of routine investigation or staging for prostate cancer
• Aged 18-80 years
• 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 hepatitis
• Those allergic to any of the ingredients of the broccoli soups
• Those taking dietary supplements or herbal remedies which may affect the study outcome. Please note that some supplements may not affect the study and this will be assessed on an individual basis
• 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: Yes

Sponsors

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

OTHER

Sponsor Role: collaborator

Quadram Institute Bioscience

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Mithen, PhD

Role: PRINCIPAL_INVESTIGATOR

Quadram Institute Bioscience

Locations

Institute of Food Research

Norwich, Norfolk, United Kingdom

Countries

United Kingdom

References

Coode-Bate J, Sivapalan T, Melchini A, Saha S, Needs PW, Dainty JR, Maicha JB, Beasy G, Traka MH, Mills RD, Ball RY, Mithen RF. Accumulation of Dietary S-Methyl Cysteine Sulfoxide in Human Prostate Tissue. Mol Nutr Food Res. 2019 Oct;63(20):e1900461. doi: 10.1002/mnfr.201900461. Epub 2019 Sep 11.

Reference Type: DERIVED

PMID: 31410992 (View on PubMed)

Other Identifiers

IFR01/2016

Identifier Type: -

Identifier Source: org_study_id