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A randomized, placebo-controlled trial with healthy volunteers (n = 22) was conducted to investigate the immunomodulatory activities of a concentrated fruit and vegetable juice over a period of 7 weeks. Immune response was characterized with the True-culture (R) whole blood assay. Out of 30 cytokines significant increases (t-test, p< 0,05) were shown for the T-cell dependent cytokines GM-CSF, IFNgamma (p = 0,078), IL-4, IL-10, IL-17 and TNFbeta after 3 days of juice intake. The study confirmed former results of stable levels of cytokines over several weeks within the individual, while the variabilty between individuals can be high. Studies must be designed analyzed carefully to be able to characterize immune responses properly.
In a randomized controlled multiple cross-over trial, the effect of a single application of 1000 and 3000 F.I.P. bromelain on 6 cytokines, of male healthy volunteers was studied. The analysis of cytokines (Interferon gamma, IL-2, IL-6, IL8, IL-10, IL13 and MCP-1) was performed with the TrueCulture(tm) whole-blood culture system (EDI GmbH). With a single dose of 3000 F. I. P. bromelain, IFNgamma was found to be significantly stimulated in the afternoon hours compared to placebo (p = 0.043; Mixed Linear Model, Bonferroni adjusted).
Up to now, cytokines have been regarded as difficult parameters for the characterisation of the immune system. The study shows that, depending of the type of cytokine, the variability of these potent mediators of immune functions in fact be high high between subjects, but relatively small within a subject. By using appropriate statistical techniques, the use of cytokines as endpoints in investigational clinical studies has become possible.