title: Development of a tomato-based food for special medical purposes as therapy adjuvant for patients with HCV infection.
abstract: OBJECTIVE
  The present study aimed to develop a food for special medical purposes (FSMP) and to assess its efficacy as adjuvant therapy in patients with chronic hepatitis C virus (HCV).
  
  
  METHODS
  Open randomized clinical trials with a tomato-based FSMP used as adjuvant treatment to the pharmacological therapy with pegilated interferon and ribavirin.
  
  
  METHODS
  Eight healthy volunteers and 39 HCV patients.
  
  
  METHODS
  For the bioavailability study, healthy subjects consumed 100 g/die FSMP for a week and their serum carotenoid profile at baseline, after the week of administration and 7 days later was determined. The same quantity of FSMP for 6 months by 20 of the 39 HCV patients was consumed in the clinical trial. Serum transaminase, haemoglobin (Hb) and hydroperoxide concentrations during the therapy were monitored in all patients.
  
  
  RESULTS
  FSMP consumption caused a fourfold increase of lycopene serum concentration in healthy subjects. A significant increase of carotenoids after 1 month of consumption also in patients with HCV was recorded. Transaminase and Hb serum levels, as well as therapeutic response, were not influenced by FSMP. The decrease in serum hydroperoxides was independent from FSMP consumption in long-term responder patients, whereas nonresponder (NR) patients of FSMP group showed higher reductions than NR patients of Control group.
  
  
  CONCLUSIONS
  The FSMP was effective in improving carotenoid status in healthy subjects. In HCV patients, it did not influence the therapeutic response, but it prevented carotenoid serum depletion and it was effective in improving the oxidative status during antiviral therapy in NR patients.
authors.affiliation: Department of Food Science, University of Naples Federico II, Parco Gussone, Portici (NA), Italy.
authors.forename: P
authors.initials: P
authors.lastname: Vitaglione
authors.forename: V
authors.initials: V
authors.lastname: Fogliano
authors.forename: S
authors.initials: S
authors.lastname: Stingo
authors.forename: L
authors.initials: L
authors.lastname: Scalfi
authors.forename: N
authors.initials: N
authors.lastname: Caporaso
authors.forename: F
authors.initials: F
authors.lastname: Morisco
mesh_terms: D000277:Adjuvants, Pharmaceutic; D000328:Adult; D000368:Aged; D000975:Antioxidants / Q000493:pharmacokinetics*; D000998:Antiviral Agents / Q000627:therapeutic use; D001682:Biological Availability; D002338:Carotenoids / Q000097:blood / Q000493:pharmacokinetics*; D005260:Female; D006526:Hepatitis C / Q000097:blood*; D006801:Humans; D000077276:Lycopene; D018551:Solanum lycopersicum / Q000737:chemistry; D008297:Male; D008875:Middle Aged; D009752:Nutritional Status; D010084:Oxidation-Reduction
chemical_list: D000277:Adjuvants, Pharmaceutic; D000975:Antioxidants; D000998:Antiviral Agents; D002338:Carotenoids; D000077276:Lycopene