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Randomized Controlled Trial
. 2024 Aug 26;16(17):2850.
doi: 10.3390/nu16172850.

From Vineyard to Vision: Efficacy of Maltodextrinated Grape Pomace Extract (MaGPE) Nutraceutical Formulation in Patients with Diabetic Retinopathy

Elisabetta Schiano  1 , Sabrina Vaccaro  2 , Vincenzo Scorcia  2 , Adriano Carnevali  2 , Massimiliano Borselli  2 , Domenico Chisari  2 , Fabrizia Guerra  1 , Fortuna Iannuzzo  3 , Gian Carlo Tenore  4 , Giuseppe Giannaccare  5 , Ettore Novellino  1
Affiliations
Randomized Controlled Trial

From Vineyard to Vision: Efficacy of Maltodextrinated Grape Pomace Extract (MaGPE) Nutraceutical Formulation in Patients with Diabetic Retinopathy

Elisabetta Schiano et al. Nutrients. .

Abstract

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.

Keywords: diabetes; diabetic retinopathy; grape pomace polyphenols; macular degeneration; nutraceuticals; oxidative stress.

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Conflict of interest statement

Authors Elisabetta Schiano, Fabrizia Guerra and Ettore Novellino are from Inventia Biotech Healthcare Food Research Center s.r.l. The company had no role in the design of the study; in the collection, analysis or interpretation of the data; or in the decision to publish the results. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as potential conflicts of interest.

Figures

Figure 1
Figure 1
Study’s Consolidated Standards of Reporting Trials (CONSORT) flow diagram.
Figure 2
Figure 2
Percentage of changes in central foveal thickness after 3-month (T3) and 6-month (T6) treatment in the group treated with DEX injection + MaGPE nutraceutical formulation (MaGPE group) and the group treated with DEX injection + maltodextrins (Placebo group). Data are expressed as mean ± SEM. Statistical significance was calculated by 2way ANOVA followed by Tukey’s multiple comparisons test. ** p ≤ 0.01, **** p < 0.0001, significantly different vs. T0 within each group; ### p ≤ 0.001, significantly different vs. MaGPE group at the same time point of analysis.
Figure 3
Figure 3
Percentage of changes in visual acuity after 3-month (T3) and 6-month (T6) treatment in the group treated with DEX injection + MaGPE nutraceutical formulation (MaGPE group) and the group treated with DEX injection + maltodextrins (Placebo group). Data are expressed as mean ± SEM. Statistical significance was calculated by 2way ANOVA followed by Tukey’s multiple comparisons test. ** p < 0.01, *** p < 0.001, significantly different vs. T0 within each group; #### p ≤ 0.0001, significantly different vs. MaGPE group at the same time point of analysis.
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