From Vineyard to Vision: Efficacy of Maltodextrinated Grape Pomace Extract (MaGPE) Nutraceutical Formulation in Patients with Diabetic Retinopathy.
Elisabetta SchianoSabrina VaccaroVincenzo ScorciaAdriano CarnevaliMassimiliano BorselliDomenico ChisariFabrizia GuerraFortuna IannuzzoGian Carlo TenoreGiuseppe GiannaccareEttore NovellinoPublished in: Nutrients (2024)
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 ( p < 0.001) and T6 ( p < 0.01), a reduction in CRT (at T3 and T6, both p < 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 ( p < 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 ( p < 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.
Keyphrases
- diabetic retinopathy
- oxidative stress
- low density lipoprotein
- double blind
- editorial comment
- placebo controlled
- optical coherence tomography
- clinical trial
- phase ii
- diabetic rats
- dna damage
- end stage renal disease
- phase iii
- ischemia reperfusion injury
- open label
- induced apoptosis
- drug delivery
- newly diagnosed
- study protocol
- ejection fraction
- chronic kidney disease
- heart failure
- type diabetes
- heat shock
- magnetic resonance imaging
- anti inflammatory
- patient reported outcomes
- rectal cancer
- signaling pathway
- patient reported
- locally advanced