Inventia Biotech-Healthcare Food Research Center s.r.l., Strada Statale Sannitica KM 20.700, 81020 Caserta, Italy.
Department of Ophthalmology, University Magna Graecia of Catanzaro, 88100 Catanzaro, Italy.
Nutrients. 2024 Aug 26;16(17):2850. doi: 10.3390/nu16172850.
Despite recent advances, pharmacological treatments of diabetic retinopathy (DR) do not directly address the underlying oxidative stress. This study evaluates the efficacy of a nutraceutical formulation based on maltodextrinated grape pomace extract (MaGPE), an oxidative stress inhibitor, in managing DR. A 6-month, randomized, placebo-controlled clinical trial involving 99 patients with mild to moderate non-proliferative DR was conducted. The MaGPE group showed improvement in best-corrected visual acuity (BCVA) values at T3 ( < 0.001) and T6 ( < 0.01), a reduction in CRT (at T3 and T6, both < 0.0001) and a stabilization of vascular perfusion percentage, with slight increases at T3 and T6 (+3.0% and +2.7% at T3 and T6, respectively, compared to baseline). Additionally, the levels of reactive oxygen metabolite derivatives (dROMs) decreased from 1100.6 ± 430.1 UCARR at T0 to 974.8 ± 390.2 UCARR at T3 and further to 930.6 ± 310.3 UCARR at T6 ( < 0.05 vs. T0). Similarly, oxidized low-density lipoprotein (oxLDL) levels decreased from 953.9 ± 212.4 µEq/L at T0 to 867.0 ± 209.5 µEq/L at T3 and markedly to 735.0 ± 213.7 µEq/L at T6 ( < 0.0001 vs. T0). These findings suggest that MaGPE supplementation effectively reduces retinal swelling and oxidative stress, contributing to improved visual outcomes in DR patients.
尽管最近取得了进展,但治疗糖尿病视网膜病变(DR)的药物治疗并不能直接解决潜在的氧化应激问题。本研究评估了基于麦芽糖糊精化葡萄渣提取物(MaGPE)的营养配方的疗效,MaGPE 是一种抗氧化应激抑制剂,用于治疗 DR。一项为期 6 个月、随机、安慰剂对照的临床试验纳入了 99 名轻度至中度非增生性 DR 患者。MaGPE 组在 T3(<0.001)和 T6(<0.01)时最佳矫正视力(BCVA)值改善,T3 和 T6 时 CRT 降低(均<0.0001),血管灌注百分比稳定,T3 和 T6 时略有增加(分别增加 3.0%和 2.7%,与基线相比)。此外,活性氧代谢物衍生物(dROMs)水平从 T0 时的 1100.6±430.1 UCARR 降至 T3 时的 974.8±390.2 UCARR,进一步降至 T6 时的 930.6±310.3 UCARR(<0.05 与 T0 相比)。同样,氧化型低密度脂蛋白(oxLDL)水平从 T0 时的 953.9±212.4 µEq/L 降至 T3 时的 867.0±209.5 µEq/L,显著降至 T6 时的 735.0±213.7 µEq/L(<0.0001 与 T0 相比)。这些发现表明,MaGPE 补充剂可有效减轻视网膜肿胀和氧化应激,从而改善 DR 患者的视力预后。