Sulphate Accumulation in Prostate (SAP)
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|ClinicalTrials.gov Identifier: NCT02821728|
Recruitment Status : Completed
First Posted : July 4, 2016
Last Update Posted : June 2, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Dietary Supplement: Dietary intervention Other: Normal diet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pre-Biopsy Window of Opportunity Trial to Measure Sulphate Levels in Human Prostate After Broccoli Consumption|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||April 2017|
Experimental: Normal diet
No dietary intervention
Other: Normal diet
Participants in this group will continue with their normal diet up until the day of their scheduled template prostate biopsy.
Experimental: Dietary intervention
3 portions of broccoli soup per week
Dietary Supplement: 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.
- Sulphate level [ Time Frame: Biopsy on a single occasion at ≥ 4 weeks ]Sulphate levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.
- ADP [ Time Frame: Biopsy on a single occasion at ≥ 4 weeks ]Adenosine diphosphate (ADP) levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.
- Redox status of phosphatase proteins [ Time Frame: Biopsy on a single occasion at ≥ 4 weeks ]The redox status of phosphatase proteins, including the tumour suppressor PTEN will be assessed in biopsy tissue samples from the prostate gland.
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821728
|Institute of Food Research|
|Norwich, Norfolk, United Kingdom, NR4 7UA|
|Principal Investigator:||Richard Mithen, PhD||Quadram Institute Bioscience|
|Responsible Party:||Quadram Institute Bioscience|
|Other Study ID Numbers:||
|First Posted:||July 4, 2016 Key Record Dates|
|Last Update Posted:||June 2, 2017|
|Last Verified:||June 2017|
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