Belcaro Gianni, Saggino Aristide, Cornelli Umberto, Luzzi Roberta, Dugall Mark, Hosoi Morio, Feragalli Beatrice, Cesarone Maria R
IRVINE3 Labs, Chieti-Pescara University, Chieti, Italy -
International Agency for Pharma Standard Supplements (IAPPS), Chieti, Italy -
J Neurosurg Sci. 2018 Aug;62(4):423-427. doi: 10.23736/S0390-5616.18.04384-9.
Oxidative stress (OS) plays a substantial role in inflammatory and neurodegenerative diseases, causing cellular damage and mitochondrial dysfunction. OS also contributes to aging and severe neural disorders such as Alzheimer's and Parkinson's diseases. Previous registries have documented a reduction in OS levels with Robuvit® (Horphag Research, Ltd.), an extract from wood of the French oak (Quercus robur) that provides a decrease of OS as well as relief from chronic fatigue syndrome. The aim of the present registry was to investigate the influence of Robuvit® on a group of subjects presenting with mood disorders, oxidative stress, fatigue, and insomnia.
Forty patients were recruited from a selection of patients with high OS levels as assessed with the d-ROMs test. Twenty-two subjects formed the control group following the standard management plan. The remaining 18 subjects formed the Robuvit® supplementation group. They received three capsules of Robuvit® 100 mg per day, for 8 weeks.
Tolerability to the supplementation with Robuvit® was overall good, and no safety concerns were raised. Mood tests showed a significant general improvement in 13 out of 16 items of the BMIS (P<0.05) in the active treatment group. Oxidative stress levels decreased significantly with Robuvit® supplementation after 4 and 8 weeks. Fatigue and insomnia score were also significantly better in supplemented subjects (P<0.05). No changes were observed in controls.
The observed decrease in OS levels in our patients is probably the result of the antioxidative activity of Robuvit®, and, more precisely, of its active metabolites, the urolithins and ellagic acid.
氧化应激（OS）在炎症和神经退行性疾病中起重要作用，可导致细胞损伤和线粒体功能障碍。OS还与衰老以及阿尔茨海默病和帕金森病等严重神经疾病有关。先前的登记研究记录了服用法国橡木（栎属）提取物Robuvit®（霍法格研究有限公司）后氧化应激水平的降低，该提取物可降低氧化应激水平并缓解慢性疲劳综合征。本登记研究的目的是调查Robuvit®对一组患有情绪障碍、氧化应激、疲劳和失眠的受试者的影响。
从经d-ROMs测试评估为氧化应激水平高的患者中招募了40名患者。22名受试者按照标准管理方案组成对照组。其余18名受试者组成Robuvit®补充组。他们每天服用3粒100毫克的Robuvit®胶囊，持续8周。
Robuvit®补充剂的耐受性总体良好，未引发安全问题。情绪测试显示，积极治疗组中，16项BMIS中有13项有显著的总体改善（P<0.05）。补充Robuvit®4周和8周后，氧化应激水平显著降低。补充Robuvit®的受试者的疲劳和失眠评分也显著更好（P<0.05）。对照组未观察到变化。
我们的患者中观察到的氧化应激水平降低可能是Robuvit®抗氧化活性尤其是其活性代谢产物尿石素和鞣花酸的抗氧化活性的结果。
