The UK YourPhyto Scientific Study

The UK YourPhyto Scientific Study

The UK YourPhyto Scientific Study: Combining a probiotic supplement and a next-generation phytochemical-rich food capsule to support men with indolent prostate cancer – A double-blind, randomized, placebo-controlled study

Combination of a probiotic supplement and a next-generation phytochemical-rich nutritional capsule to support men with indolent prostate cancer – A double-blind, randomized, placebo-controlled study

Background:

Emerging research links poor gut health (dysbiosis) to an increased risk and progression of prostate cancer (PCa). Various dietary and lifestyle factors influence dysbiosis, but probiotic supplements have also been shown to improve the microbiome, shifting it toward a more favorable, less inflammatory profile. Similarly, studies have associated a higher intake of phytochemical-rich foods with a lower risk of PCa and slower progression of prostate-specific antigen (PSA). Phytochemicals possess numerous direct and indirect anticarcinogenic properties, including reducing excess chronic inflammation and promoting oxidative pathways; however, they also act as prebiotics, supporting commensal and ingested probiotic bacteria.

The hypothesis of this double-blind, randomized study is that a probiotic supplement could enhance the benefits of a phytochemical-rich supplement through this synergistic effect. A combination of phytochemical-rich foods and probiotic supplements had not previously been investigated in a cohort of men with prostate cancer, which is the rationale for this study.

The aim is to determine whether supplementing the diet with a Lactobacillus probiotic in addition to a phytochemical-rich food supplement affects PSA progression, prostate-related symptoms, and strength in men with early PCa compared to placebo.

Intervention and rationale for the use of these nutraceutical supplements:

The advantage of using supplements instead of simply changing one's diet in clinical trials is that healthy foods can be specifically increased, quantified, and purified throughout the day. Furthermore, it is more difficult, especially with a typical UK diet, to regularly consume sufficient amounts of probiotics.

Hundreds of commercial probiotics are available, however this particular probiotic complex preparation was selected because it meets all the important criteria established by the scientific committee:

• high number of colony-forming units (10 billion CFU)

• Integrated prebiotics (inulin and vitamin D) to support colony formation

• delayed-release vegan capsule

• Manufactured by an established UK manufacturer with high quality certification

• evaluated in previous clinical studies and found to be safe and well tolerated

The scientific committee selected this specific phytochemical-rich mixture after a formal review of the international scientific literature. Based on this data, the committee was able to draw on experience from its own previous studies as well as from international publications of the last 10 years.

Manufacturers were also able to integrate new technologies in purification, quality assurance, and standardization to ensure consistency of the target phytochemicals. All these factors led to the development of a next-generation supplement with several novel and attractive features:

• A combination of six uniquely different food types

• Provision of a broad spectrum of natural phytochemicals

• Avoiding an overdose of a single type of phytochemical

• Combination of full concentrates and extracts

• Minimum target amounts of phytochemicals are measured and standardized.

• Contains no foods with phytoestrogenic properties

• Ingredients with a high safety profile

• Manufactured by an established UK manufacturer with high quality certification

• evaluated in previous clinical studies and found to be safe and well tolerated

Methodology:

The study cohort includes men with histologically confirmed prostate cancer (PCa) who are not receiving androgen deprivation therapy (ADT) and are being monitored under active surveillance or watchful waiting.

After providing written consent, all participating men (180) will receive the phytochemical-rich dietary supplement and will be asked to discontinue all other over-the-counter supplements.

Participants will be randomly assigned to receive either a probiotic supplement or a placebo in a double-blind, randomized (1:1) manner.

The supplements are taken twice daily for a period of 4 months.

Study endpoints:

The PSA doubling time (PSAdt) is measured at the beginning and after 4 months, along with testosterone levels and measurements of prostate-related symptoms and general well-being:

• Vitamin D levels

• International Prostate Symptom Score (IPSS)

• International Index of Erectile Function

• Grip strength as a marker of general well-being

Certification and timeframe:

This national UK study will initially be conducted by a team from Bedford and Addenbrooke's Cambridge University NHS Trusts.

The Chief Medical Officer is Mr. Frazilli, a specialist in urology with a specialization in prostate cancer diagnostics and therapy.

The study design was peer-reviewed and registered with the UK National Ethics Committee (Ethics (IRAS) number: 321309) and internationally with the ISRCTN (ISRCTN 81939514).

ISRCTN is an independent registry where the public can view details of the study, recruitment progress, and publication periods.