Efficacy and safety of YHC-BE-2040 on immune function: An 8-week, multicenter, randomized, double-blinded, and placebo-controlled study

초록

Background:Deer velvet (DV) extract, a traditional remedy in Eastern Asian medicine, holds potential as an immune modulator. This study aimed to investigate the effects of enzymatically digested DV extract, YHC-BE-2040 (HENKIV (R)), on cell-mediated immunity in a randomized controlled trial. Methods:Healthy adults (N = 120), aged 40 to 70, were randomly assigned to receive either a high-dose (HD) or low-dose (LD) DV extract, or a placebo daily for 8 weeks. The subjects were instructed to orally administer the provided intervention once a day, taking 2 capsules per dose after a meal. Results:Primary efficacy was measured by natural killer-cell activity, revealing a significant increase in both HD and LD groups compared to placebo (P < .05). Notably, a dose-response relationship was observed, with the HD group exhibiting the most substantial improvement. Secondary parameters TNF-alpha, IFN-gamma, IL-2, and IL-6 showed significant increases in IFN-gamma for HD and LD groups. Safety analysis revealed that YHC-BE-2040 was well-tolerated, with no serious adverse events. Reported adverse events were mild to moderate and not definitively linked to the intervention. Conclusion:This study provides meaningful insights into the potential of YHC-BE-2040 as an immune function modulator. While promising, further research with clinical endpoints, larger sample sizes, and extended study durations is needed to fully understand the mechanisms and long-term effects of this deer antler extract on human immunity. Nevertheless, these findings support the safe and effective use of YHC-BE-2040 as an immune-enhancing dietary supplement in healthy adults.

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