PGN, MP, VF and SI are shareholders at Janus Pharma srl.
To evaluate the efficacy and safety of a novel tomato-based food supplement on the lower urinary tract symptoms (LUTS) of patients with benign prostatic hyperplasia (BPH).
Twenty patients with BPH were enrolled in this observational study. They were assigned to consume daily a sachet of Lycoprozen® (5 grams) dissolved in water for two months.
All patients successfully completed the Lycoprozen scheduled regimen and the IPSS (International Prostatic Symptom Score) questionnaire before and after treatment. No side effects due to treatment were noticed. In this preliminary study, we have found that Lycoprozen® significantly reduced the LUTS severity (paired
Based on these data, Lycoprozen® may represent a suitable alternative option for the treatment of symptomatic BPH patients which worth of further testing in a phase 2 prospective randomized double blind placebo controlled study. The treatment was without side effects and acceptance among patients was high.
Benign prostatic hyperplasia BPH affects aging men and represents the most common urologic disease among elderly men
The diagnosis of BPH is often in response to the development of lower urinary tract obstructive, irritative, and post-micturition symptoms (LUTS), including urinary hesitancy, urgency, frequency and post void dribble. Medical treatment options include α-adrenergic antagonists or 5-α reductase inhibitors, however about one-third of men with LUTS do not respond to either treatment approach
Further understanding the causes of LUTS will guide interventions to prevent LUTS or increase sensitivity to medical treatment. To date, there are multiple theories on the cellular and molecular processes underlying the pathogenesis of BPH leading to a symptomatic disease. In addition to androgens, both chronic and acute inflammation can lead to events that can cause proliferation within prostatic tissue through a variety of mechanisms, notably oxidative stress
BPH is also associated with obesity and related pathologies. However, the biological pathways linking obesity and BPH are poorly understood. Centralized adipose deposition was associated with the severity of prostate tissue inflammation and LUTS and an approach to minimize centralized fat deposition may reduce LUTS severity in BPH patients
A large number of anti-inflammatory compounds has been identified in tomato extracts
We have also observed that a feed enriched with a 10% whole tomato preparation versus a tomato-free control feed is able to increase the anti-oxidant serum activity and to reduce serum levels of inflammatory biomarkers in the TRAMP mouse model of prostate carcinogenesis, even before the appearance of cancer
Recently, a novel food supplement named Lycoprozen® was developed by Janus Pharma, Roma, Italy. It consists of whole tomatoes specially processed for make their antioxidant and anti-inflammatory micronutrients highly bioavailable, and a small percentage of olive’s vegetation water. In the present study, we have evaluated the effects of Lycoprozen® on the LUTS severity in subjects affected by BPH.
Lycoprozen® is available as food supplement on the Italian market since 2017 with the Ministry of Health registration number 68843. The patented multi-step production process results into an increased bioavailability of antioxidant and anti-inflammatory tomato micronutrients, which include carotenoids (mainly lycopene), flavonoids, and ketosamines
The compositions of the tomato powder and polyphenolic extract from olive vegetation water are reported in
Carbohydrates (g) | 64,5 |
Proteins (g) | 10.2 |
Lipids (g) | 3.4 |
Carotenoids (mg) | 500 |
Lycopene isomers (mg) | 190 |
Alpha-tocopherol (mg) | 2.3 |
Total flavonoids (mg) | 200 |
Ketosamines (mg) | 8 |
Fibers (g) | 15.9 |
Humidity (g) | < 5 |
Oleuropeinaglycon | 6% |
Ligtrosideaglycon | 2% |
Oleuropeindialdialdehydeaglycon | 6% |
Ligtrosidedialdehydeaglycon | 7% |
Verbascoside | 6% |
Pinoresinolo and Deacetoxypinoresinolo | 5% |
Tyrosol | 3% |
Hydroxytyrosol | 10% |
Undentified polyphenols | 8% |
Twenty patients with BPH were enrolled in this observational study. All patients underwent clinical and instrumental examinations and completed the IPSS (International Prostatic Symptom Score) questionnaire
All patients successfully completed treatment with no side effects.
The IPSS is based on the answer to seven questions concerning urinary symptoms, and is the only questionnaire validated by WHO in Italian language. Each question is assigned points from 0 to 5, indicating increasing severity of a particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Although there are presently no standard recommendations into grading patients with mild, moderate or severe symptoms, patients can be tentatively classified as follows: 0 - 7 = mildly symptomatic; 8 - 19 = moderately symptomatic; 20 - 35 = severely symptomatic.
In this preliminary study, we have found that Lycoprozen® significantly reduced the LUTS severity (paired
As reported above, Lycoprozen® is a mixture of two components, tomato powder and a polyphenolic extract from olives.
The original tomato powder was firstly developed to produce a food for special medical purposes (FSMP) and investigated as an adjuvant therapy in patients with chronic hepatitis C infection. Our results showed that this FSMP was effective in improving carotenoid status in healthy subjects, whereas in patients with hepatitis, it prevented carotenoid serum depletion and improved the oxidative status during antiviral therapy
Next, the anti-neoplastic activity of tomato preparation was analyzed in the transgenic adenocarcinoma of the mouse prostate (TRAMP) model
The patented method to produce Lycoprozen® leads to a final product enriched in bio-active compounds which have been found more active in reducing serum levels of IL-6 and VEGF in TRAMP mice
The present observational study revealed that a once-daily intake of Lycoprozen® for two months significantly improved urinary symptoms and quality of life in patients with BPH.
BPH has been shown to be associated with an inflammatory environment, which is known to sustain proliferative programs resulting in nodules of BPH
Based on these preliminary data, Lycoprozen® may be a suitable alternative option for the treatment of symptomatic BPH patients. The treatment was without side effects and acceptance among patients was high.
The aim of the present study was to assess the short-term efficacy of Lycoprozen®. However, its value is limited by the absence of a control group. This should therefore be considered as a starting point for future studies. Currently, we are actively recruiting BPH patients in a phase II prospective, randomized, double-blinded, placebo-controlled study (participating Institutions: National Cancer Institute Regina Elena, Roma, Italy and Foggia’s University, Foggia, Italy). This study is aimed at investigating the effects of Lycoprozen® on biomarkers of lipid peroxidation, inflammation and angiogenesis, serum levels of PSA and carotenoids, mainly lycopene.
All patients signed an informed consent (agreement) before the study.