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Randomized Controlled Trial
. 2022 Oct 11;14(20):4235.
doi: 10.3390/nu14204235.

Antioxidant Efficacy of a Standardized Red Orange (Citrus sinensis (L.) Osbeck) Extract in Elderly Subjects: A Randomized, Double Blind, Controlled Study

Vincenzo Nobile  1 , Marta Pisati  1 , Enza Cestone  1 , Violetta Insolia  2 , Vincenzo Zaccaria  3 , Giuseppe Antonio Malfa  4   5
Affiliations
Randomized Controlled Trial

Antioxidant Efficacy of a Standardized Red Orange (Citrus sinensis (L.) Osbeck) Extract in Elderly Subjects: A Randomized, Double Blind, Controlled Study

Vincenzo Nobile et al. Nutrients. .

Abstract

The world population is rapidly aging. This should cause us to reflect on the need to develop a new nutritional approach to mitigate the accumulation of reactive oxygen species (ROS)-induced damage. A randomized, double blind, controlled study was carried out on 60 elderly male and female subjects. Product efficacy was measured before and after 2 and 8 weeks of product intake. The reduced (GSH) and oxidized (GSSG) glutathione concentrations in the erythrocytes and the reactive oxygen metabolites (d-ROMs) hematic concentration were measured to assess the antioxidant efficacy. The tumor necrosis factor-alpha (TNF-α) levels in the serum were measured to assess the anti-inflammatory effectiveness. The wellbeing was assessed by Short Form Health Survey (SF-36) questionnaire (male) and by Menopause Rating Scale (MRS) (female). Blood, urine analysis and electrocardiography (ECG) were carried out to assess the product's safety. The results showed that GSH/GSSG ratio increased by 22.4% and 89.0% after 2 and 8 weeks of product intake. Serum TNF-α levels decreased by 2.5% after 8 weeks of product intake. The SF-36 QoL and the MRS questionnaire outputs indicate, preliminarily, a positive effect of the extract intake in ameliorating the wellbeing of both male and female subjects. The product was well-tolerated. Our findings suggest that the test product has antioxidant and anti-inflammatory efficacy and has a positive effect on the wellbeing of elderly female and male subjects.

Keywords: aging; food supplement; menopause; oxidative stress; plant secondary metabolites; red orange extract.

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Conflict of interest statement

V.Z. is a Bionap S.r.l. employee. This does not alter the author’s adherence to all the journal policies on sharing data and materials. The other authors declare no conflict of interest. The funder had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1
Figure 1
Participants flow diagram.
Figure 2
Figure 2
(a) Reduced glutathione (GSH). (b) Oxidized glutathione (GSSG). (c) GSH/GSSG ratio. (d) d-ROMs hematic concentration. Data are average (± standard error). The intergroup statistical analysis is reported above the bar as follows: * p < 0.05, ** p < 0.01, and *** p < 0.001.
Figure 3
Figure 3
(a) Output of selected items of Menopause rating scale questionnaire 8 weeks after product use. (b) Serum TNF-α levels. Data are average (± standard error). The intergroup statistical analysis is reported above the bar as follows: bl borderline, * p < 0.05.
See this image and copyright information in PMC

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