Abstract
Ulmus macrocarpa extract has been shown to have immune-related effects in animals, but no studies have yet been performed in humans. This randomized, double-blind, placebo-controlled trial was conducted to determine the effect of short-term administration of Ulmus macrocarpa Hance extract (UME) on immune function biomarkers and its safety in human subjects. Fifty-eight subjects were randomly assigned to a UME group or a placebo group. Subjects in the UME group were given 500 mg per day of UME orally for 4 weeks. Mean fluorescence intensity (MFI) of tumor necrotic factor-α increased only in the UME group at 1 week (P = 0.027). The MFI of interleukin-2 decreased less significantly in the UME group than in the placebo group at 1 week (P = 0.028). However, unfortunately, at 4 weeks, no intergroup differences were detected in MFIs of cytokine. In conclusion, administration of UME for 1 week increased serum TNF-α and sustains IL-2 in human, which suggests that UME increases Th1-related immune function in the short term in healthy people. However, additional studies are needed to confirm the results of this first-stage study and further trials are required to decide on optimal dosage and duration of administration. This trial is registered with ClinicalTrials.gov Identifier: NCT02414412.
Highlights
Tremendous advances in medical technology have nearly doubled life expectancy over the past century [1]
58 subjects were randomly assigned into two groups, Ulmus macrocarpa Hance extract (UME) group (n = 29) and placebo group (n = 29)
The UME and placebo groups were comparable with respect to most variables; no significant intergroup differences were observed between baseline demographics, anthropometrics, or body temperatures (Table 1)
Summary
Tremendous advances in medical technology have nearly doubled life expectancy over the past century [1]. Abnormal circadian rhythms, industry, modern life, a sedentary lifestyle, and unhealthy diets have been linked with depression of the immune system, obesity, and diabetes mellitus. For this reason, considerable efforts are being made to enhance the immune system [3]. Immune response can be classified as innate or adaptive. These responses involve complements, various cytokines and macrophages, natural killer (NK) cells, and lymphocytes, and reduced activities of these cells are associated with reduced immune system effectiveness [4]
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