Worlds first gut health intervention to help men with prostate cancer completes recruitment
Thanks to the help of three prostate cancer support groups a major UK clinical study completed a year ahead of schedule – 220 men successfully recruited in just 7 months which highlights the boom in interest in gut health at the moment. This was the World’s first randomised clinical trial which evaluated an intervention to improve gut health in men with prostate cancer.
This double blind randomised trial study, had a novel design which was largely advised by men living with prostate cancer themselves – almost certainly one reason for its success. In order that the results could be statistically valid, men would have had to stop all existing supplements then be randomised to the intervention (a specifically designed probiotic, prebiotic, vitamin D blend) or placebo. However, due to evidence from previous studies showing benefits for phytochemical rich supplements they were not willing to stop these. So, in order to create a level playing field, and satisfy their wishes, all men in the study had to be given the same phytochemical rich supplement. Instead of using an existing blend the scientific committee used this opportunity to design a new supplement utilising the next generation of food technology and safety. As a consequence of this design the trial asked two fundamental questions
1. Could an intervention to improve gut health, in the form of a probiotic, vitamin D supplement reduce disease progression and improve symptoms in men with existing prostate cancer.
2. Could a next generation, phytochemical rich food capsule reduce progression of prostate cancer and improve urinary symptoms over existing nutritional strategies
The trial was led by the same team of doctors and nutritional scientists from Bedford and Addenbrooke’s Cambridge University Hospitals who conducted a similar study 14 years ago. This time, they linked up with prostate and gut health experts from Australia, California and London. This time the study involved men with progressive prostate cancer who were given the opportunity to try these nutritional interventions before considering radical treatments or hormone therapies, which have significant risks and toxicities which impact quality of life.
The trial, therefore, boosted daily intake of phytochemical rich foods using a new nutritional supplement, now referred to as Yourphyto. This blend still contains the same quantities of pomegranate, broccoli, green tea and turmeric, shown to be beneficial in the original study, but it has been upgraded. This included detection and exclusion of contaminants such as heavy metals and pesticides as well as measurement and standardisation of the candidate phytochemical ensuring each maintains its effectiveness and safety.
Traditionally, supplements either have extracts of plants or dried whole plants – uniquely, this new supplement has both. This has, not only, ensured a wide spectrum of synergistically acting natural elements from the whole plant, but significantly higher levels of the most active phytochemicals responsible for the health benefits. Furthermore, since 2013 other foods have been shown to benefit men with prostate cancer, particularly cranberry and organic ginger, both of which have been added to this new design. Cranberry has been shown to reduce markers of disease progression and help urinary urgency, especially if combined with other anti-inflammatory foods such as these. Ginger, helps with digestion and gut health and is a known bioenhancer, meaning it promotes the absorption of healthy phytochemicals from other plants. As this capsule was specifically made for a national medical trial, the ethical committee insisted on a level of quality assurance unprecedented in supplement manufacturing.
Phytochemicals help fight cancer, and many other chronic disease such as dementia, diabetes, arthritis and heart disease by dampening down excess inflammation and supporting anti-oxidative pathways which protect our DNA from by-products of energy production and toxic chemicals. They also slow the transfer of processed sugar through the gut wall, improve vitamin D absorption, directly slow the growth of cancer cells and act as prebiotics which helps support healthy bacterial growth and hence improve gut wall integrity. It is not a surprize that laboratory studies show they, not only, help colonisation of beneficial probiotic bacteria after intake. In return, probiotic bacteria assist the breakdown of larger phytochemicals to more biologically active components. With this background evidence it’s surprising that there have been no clinical studies combining phytochemical with probiotic supplements in men with prostate cancer before this one.
In this study, all men were given the open label phytochemical rich supplement (Yourphyto) and were asked to stop all other over the counter supplements. They were then randomised to receive either a dummy capsule (placebo) or a capsule containing probiotics with similar packaging. A process called blinding, so both the participant of doctors did not know what they were taking until the end of the evaluation, a tactic which eliminates bias in data recording.
The probiotic capsules, now commercial known as yourgutplus+, contain 5 non-histamine inducing, lactose secreting lactobacillus bacterial strain, combined with a 1000iu of vitamin D and a good quantity of a prebiotic called inulin, made from chicory. It has a delayed release vegan capsule and no artificial preservatives, colours, and sweeteners which could have adversely affect bacteria growth. The aim of this supplement is to shift the profile of bacteria in the gut from an inflammatory to an anti-inflammatory profile. Reassuringly, it was proven to be safe and beneficial in two previous covid studies.
The average age of the men in the study was 68 years, they all had histologically confirmed prostate cancer and were not taking hormones therapies. Some were managed with active surveillance and others were experiencing a PSA relapse post radiotherapy or surgery. They took the trial supplements for 4 months.
RESULTS
The final official results will be presented in January 2025, but the interim analysis presented by the research team had already showed significant benefits for PSA reduction, improvements in urinary symptoms and erectile function. Most men chose to continue these supplements post trial, including the 80 men who had previously been taking the old supplement pretrial.
Men in the trial received these supplements free of charge, however, because they are classed as food supplements, not drugs, they cannot be prescribed by doctors despite this formal medical evaluation. All men were given a post-trial diet and lifestyle sheet with advice on how to improve gut health and phytochemical food intake. In addition and fortunately, since the end of the study the manufactures have made them available via their websites; Yourphyto.com and Yourgutplus.com.
The much anticipated results have now been analysed by the auditors and will be announced to the World at the largest and prestigious cancer conference (ASCO Urology) in January 2025.
More information on the rationale and background for the trial can be found on the trials website.gut
Leave A Comment