Improvement of Urinary Tract Symptoms and Quality of Life in Benign Prostate Hyperplasia Patients Associated with Consumption of a Newly Developed Whole Tomato-Based Food Supplement - Beyond the Abstract

Benign prostatic hyperplasia (BPH), frequently affecting elderly men, is associated with bothersome lower urinary tract symptoms (LUTS) and represents a growing nosological entity in terms of health care costs and morbidity. Current pharmacological treatments include 5-α reductase inhibitors, α-adrenergic antagonists, and non-steroidal anti-inflammatory drugs. However, a distinct proportion of patients with LUTS do not respond to treatment and a fraction of responders is penalized by the occurrence of side effects as loss of libido, sexual dysfunction, hypotension, and others. As a consequence, unresponsive patients, and those becoming resistant to treatment will become candidates for surgical intervention to reduce LUTS severity.

Available data indicated that tailored diet habits could help to reduce the incidence of prostatic cancer (PCa) and BPH and could be used in a multimodal approach for the management of these diseases. Indeed, epidemiological and observational studies have consistently demonstrated that intake of tomato more than its primary bioactive compound, lycopene, reduces the risk for PCa and delays disease progression in patients with BPH,1,2 but few controlled clinical trials have been so far performed. In these trials, lycopene supplementation and nutritional interventions with tomato products were found able to decrease serum prostate-specific antigen (PSA) levels.3,4 Again, according to a nested case-control study at least ten portions (one portion = 150g) of tomatoes a week lowered the risk of prostate cancer by 20%.5

Regarding BPH, we have very recently shown in a prospective phase II randomized, double-blinded, placebo-controlled study, the efficacy, and safety of a novel whole tomato-based food supplement (WTFS).6 This supplement obtained by a patented solvent-free process is characterized by increased bioavailability of anti-oxidant and anti-inflammatory tomato micronutrients: carotenoids, main lycopene with increased cis-configuration, flavonoids, and ketosamines added with a small percentage of olive polyphenols.7 It was found to significantly improve the oxidative status, reducing serum levels of IL-6 and VEGF, delaying tumor progression, and decreasing both poorly differentiated carcinoma incidence and mortality in a transgenic mouse model of prostate carcinogenesis.8 The WTFS uptake also consistently reduced LUTS of patients with histologically proven BPH. In particular, reduced frequency and urgency resulting in a significant improvement in life quality.6 In addition, free/total PSA ratios were not significantly different before and after the WTFS treatment. It is worthy to note that, due to the preparation procedures, this WTFS does not contain organic acids (citric and malic acids), significant potassium/oxalate concentration and tomato skin/seeds, responsible for some side effects (gastroesophageal reflux disease, irritable bowel syndrome, kidney stones, and some urinary problems) reported following consumption of the fruit.9 In addition, based on recent human experimentation,10 this supplement, which is phytosterol-free may help to maintain prostate health and can contribute to the beneficial effect of adhering to the WCRF/AICR recommendations.5 In conclusion, this novel WTFS may represent an efficient and safe option for the treatment of symptomatic BPH patients.

Written by: Mauro Piantelli, MD,1 Luigi Cormio, MD,2 & Pier Giorgio Natali, MD1

  1. Dept. of Medicine and Aging Sciences, Center for Advanced Studies and Technology (CAST), G.d’Annunzio University, Chieti, Italy.
  2. Urology and Renal Transplantation Unit, Dep.of Medical and Surgical Sciences, University of Foggia, Foggia, Italy


  1. Rowles JL, 3rd, Ranard KM, Applegate CC, Jeon S, An R, Erdman JW, Jr. Processed and raw tomato consumption and risk of prostate cancer: a systematic review and dose-response meta-analysis. Prostate Cancer Prostatic Dis. 2018; 21:319-336.
  2. Patel HRH, Elbakbak W, Bouhelai A, Muller S. Does oral lycopene reduce benign prostate enlargement/hyperplasia (BPE/BPH)? Oncol Cancer Case Rep 2016; 2:1.
  3. Schwarz S, Obermuller-Jevic UC, Hellmis E, Koch W, Jacobi G, Biesalski H-K. Lycopene inhibits disease progression in patients with benign prostate hyperplasia. J Nutr. 2008; 138:49-53.
  4. Paur I, Lilleby W, Kjølsrud Bøhn S, Hulande E, Klein W, Vlatkovic L, et al. Tomato-based randomized controlled trial in prostate cancer patients: Effect on PSA. Clin Nutr. 2017; 36:672–9.
  5. Er V, Lane JA, Martin RM, Emmet P, Gilbert R, Avery KN, et al. Adherence to dietary and lifestyle recommendations and prostate cancer risk in the prostate testing for cancer and treatment (ProtecT) Trial. Cancer Epidemiol Biomarkers Prev. 2014; 23:2066–77.
  6. Cormio L, Calò B, Falagario U, Iezzi M, Lamolinara A, Vitaglione P, Silecchia G, Carrieri G, Fogliano V, Iacobelli S, Natali PG, Piantelli M. Improvement of urinary tract symptoms and quality of life in benign prostate hyperplasia patients associated with consumption of a newly developed whole tomato-based food supplement: a phase II prospective, randomized double-blinded, placebo-controlled study. J Transl Med 2021; 19:24
  7. Fogliano V, Iacobelli S, Piantelli M. “Tomato powder-based composition”. 2016; US Patent App. 15/024,165.
  8. Pannellini T, Iezzi M, Liberatore M, Sabatini F, Iacobelli S, Rossi C, Alberti S, Carmine Di Ilio C, Paola Vitaglione P, Fogliano V, Piantelli M. A dietary tomato supplement prevents prostate cancer in TRAMP mice. Cancer Prev Res. 2010;3: 1284–91.
  9. Salehi B, Sharifi-Rad R, Sharopov F, Namiesnik J, Roointan A, Kamle M, Kumar P, Martins N, Sharifi-Rad J. Beneficial effects and potential risks of tomato consumption for human health: an overview. Nutrition. 2019; 62:201–8.
  10. Chen P, Zhang W, Wang X, Zhao K, Singh Negi D, Zhuo L, Mao Q, Wang X, Zhang X. Lycopene and risk of prostate cancer: a systematic review and meta-analysis. Medicine (Baltimore). 2015;94: e1260.

Read the Abstract