The UK Prostate Nutritional Intervention Study

(Ethics /IRAS number: 321309. ISRCTN: 81939514)

This study is evaluating the impact of an intervention which aims to improve gut health, increase vitamin D and boost phytochemical rich food intake among men with prostate cancer.  To improve gut health the scientific committee chose the Yourgutplus blend as it has a proven track record both for safety and effectiveness. This national, ethically approved RCT started in September 2023.

Aims:

More specifically aims to establish whether boosting the diet with a vitamin D, lactobacillus probiotic (Yourgutplus) in addition to a phytochemical-rich food supplement (Yourphyto) will influence:

• PSA progression,
• prostate-related urinary symptoms and erectile function
• Strength and exercise levels.

The intervention:

The probiotic capsule will contain 10 billion colony forming units (CFU) of 5 lactobacillus strains with built-in prebiotics.  The phytochemical-rich capsule will contain whole foods which have previously reported potential benefits for men with prostate cancer in epidemiological, laboratory and prospective studies. The scientific committee decided on this particular phytochemical-rich blend following a formal review of the international scientific literature. With this data, the committee was able to build on experience of previous research from their studies and other studies from institutes across the World published over the last 10 years. The manufactures were also able  to incorporate new technologies in purification, quality assurance and standardisation ensuring consistency in the candidate phytochemicals. All these factor combined has resulted in establish a new generation supplement with a number of novel and attractive features:

• combines six uniquely different food types, providing a wide spectrum of natural phytochemicals, avoiding over-consumption of one particular type
• combines both whole concentrates and extracts
• minimal levels of candidate phytochemicals are measured and standardised
• contains no foods with phytoestrogen properties
• ingredients have a high safety profile
• manufactured by a well-established UK manufacturer, with high quality certification
• evaluated in previous clinical trials and found to be safe and well-tolerated.

Cohort:

Men with histologically proven, early PCa early not taking androgen deprivation therapy (ADT), managed with active surveillance or watchful waiting.

Method:

Following written informed consent, all participating men (220) will be given the phytochemical-rich food supplement and asked to stop all other over-the-counter supplements. There will be a double-blind, randomised (1:1) allocation of the probiotic supplement or placebo.  The supplements will be taken twice a day for 4 months.

Outcome measurements:

Prostatic Specific Antigen doubling time (PSAdt) will be taken at baseline and 4 months. Uniquely the study will be measuring strength as a marker of overall wellbeing. It will also be assessing prostate symptoms via:

• The International urinary symptoms questionnaire

• The International Erectile Function score

Sponsors: The study is sponsored by Bedford and Luton Hospital trusts and the supplement have been supplied, at no cost the the trials unit, from the manufactures, who had (or will have) no influence in the trial design conduct, analysis or publication of the study.