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Randomized Controlled Trial
. 2023 Jun 26;15(13):2883.
doi: 10.3390/nu15132883.

Combination of Chemically Characterized Pomegranate Extract and Hydrophilic Vitamins against Prolonged Fatigue: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Hammad Ullah  1 , Eduardo Sommella  2 , Alessandro Di Minno  1   3 , Roberto Piccinocchi  4 , Daniele Giuseppe Buccato  1 , Lorenza Francesca De Lellis  1 , Costanza Riccioni  5 , Alessandra Baldi  1 , Hesham R El-Seedi  6   7 , Shaden A M Khalifa  8 , Gaetano Piccinocchi  9 , Pietro Campiglia  2   10 , Roberto Sacchi  11 , Maria Daglia  1   6
Affiliations
Randomized Controlled Trial

Combination of Chemically Characterized Pomegranate Extract and Hydrophilic Vitamins against Prolonged Fatigue: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Hammad Ullah et al. Nutrients. .

Abstract

Prolonged fatigue is associated with non-pathological causes and lacks an established therapeutic approach. The current study is aimed at assessing the efficacy of a new food supplement (Improve™) based on a chemically characterized pomegranate extract and hydro-soluble vitamins (B complex and C). UHPLC-HRMS analysis of pomegranate extract showed the presence of 59 compounds, with gallotannins and ellagitannins being the most abundant phytochemicals. For the clinical study, 58 subjects were randomized into two groups, 1 and 2 (n = 29, each), which received either the food supplement or placebo. The effects of the food supplement against fatigue were assessed via validated questionnaires, recorded at time intervals t0 (at baseline), t1 (after 28 days), t2 (56 days), and t3 (after follow-up) in combination with the analysis of biochemical markers at t0 and t2. Fatigue severity scale (FSS) questionnaire scores were significantly decreased at the t2 and t3 time intervals in subjects treated with the food supplements, while the effect of the food supplement on a 12-Item Short Form Survey (SF-12) was not considerable. Moreover, the food supplement did not significantly affect biochemical parameters associated with fatigue and stress conditions. This study shows that the food supplement tested reduces prolonged fatigue following two months of supplementation in healthy subjects with mild prolonged fatigue.

Keywords: polyphenols; pomegranate extract; prolonged fatigue; vitamin B complex; vitamin C.

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Conflict of interest statement

C.R. is an employee of ESSERRE srl. None of the academic researchers listed as co-authors served as consultants for ESSERRE srl or received any personal compensation from ESSERRE srl.

Figures

Figure 1
Figure 1
Chromatogram of pomegranate extract, with retention times on the x-axis and relative abundance on the y-axis. Each numbered peak represents one of the compounds identified in the pomegranate extract.
Figure 2
Figure 2
CONSORT flow diagram.
Figure 3
Figure 3
Variation of the FSS score at the four measurements in the two experimental groups.
Figure 4
Figure 4
Variation of the FSS score in relation to the age of the subjects.
Figure 5
Figure 5
Variation of the SF-12 score across the four measurements in the two experimental groups.
See this image and copyright information in PMC

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