Belcaro Gianni, Cesarone Maria R, Saggino Aristide, Dugall Mark, Hu Shu, Scipione Claudia, Scipione Valeria, Cornelli Umberto, Hosoi Morio, Cotellese Roberto, Cox David, Corsi Marcello, Feragalli Beatrice
Irvine3 Labs Institute, Pescara, Italy -
OOLEX Research Center, Pescara, Italy -
Minerva Med. 2022 Jun;113(3):518-525. doi: 10.23736/S0026-4806.21.07776-4. Epub 2021 Sep 20.
The aim of this open, pilot supplement registry study was to evaluate the protective, preventive effects of Robuvit on professional-related fatigue symptoms and on aspects of cognitive functions, professional attitudes and decision-making in healthy nurses under professional stress and with increased oxidative stress.
In total, 40 subjects, aged 30-37, completed the 4-week registry study. A control group of 20 subjects used only the standard management (SM) and one group of 20 subjects took 300 mg Robuvit in addition. Safety and tolerability of Robuvit were optimal. The two registry groups were comparable at inclusion.
The overall scores of the real daily life and tasks questionnaire after 4 weeks were significantly higher in the Robuvit group (P<0.05) as compared to controls. It increased from 4.3±0.4 at baseline to 6.78±0.8 after 4 weeks of Robuvit intake and from 4.2±0.5 to 5.12±1.0 in the control group. The supplementation significantly improved the subjective perception of fatigue in comparison with controls (P<0.05). A practical professional score evaluation provided an indication of professional attitude and stamina, in difficult, stressful working conditions under continuous pressure. The results showed that after 4-week supplementation, all assessed parameters improved significantly and the difference with controls was statistically significant (P<0.05). Furthermore, oxidative stress as plasma free radicals decreased significantly in the Robuvit group (P<0.05) but not in the control group.
Robuvit supplementation appears to improve most symptoms related to work-induced fatigue, stress and cognitive function and supports stamina. Further evaluations need to be planned according to the concept of this pilot registry in a field that requires more attention.
本开放性、试点补充剂注册研究的目的是评估鲁维特(Robuvit)对处于职业压力且氧化应激增加的健康护士的职业相关疲劳症状、认知功能、职业态度和决策方面的保护及预防作用。
共有40名年龄在30 - 37岁的受试者完成了为期4周的注册研究。20名受试者组成的对照组仅采用标准管理(SM),另一组20名受试者额外服用300毫克鲁维特。鲁维特的安全性和耐受性良好。两个注册组在纳入时具有可比性。
4周后,鲁维特组的实际日常生活和任务问卷总分显著高于对照组(P<0.05)。服用鲁维特4周后,该分数从基线时的4.3±0.4提高到6.78±0.8,而对照组从4.2±0.5提高到5.12±1.0。与对照组相比,补充剂显著改善了疲劳的主观感受(P<0.05)。一项实际职业评分评估显示了在持续压力下困难、紧张的工作条件下的职业态度和耐力。结果表明,补充4周后,所有评估参数均显著改善,与对照组的差异具有统计学意义(P<0.05)。此外,鲁维特组血浆自由基形式的氧化应激显著降低(P<0.05),而对照组未降低。
补充鲁维特似乎能改善大多数与工作引起的疲劳、压力和认知功能相关的症状,并增强耐力。需要根据该试点注册研究的理念,在一个需要更多关注的领域进行进一步评估。