Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

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

Hammad Ullah
ORCID logo ,
Eduardo Sommella
,
Alessandro Di Minno
ORCID logo ,
Roberto Piccinocchi
,
Daniele Giuseppe Buccato
,
Lorenza Francesca De Lellis
,
Costanza Riccioni
ORCID logo ,
Alessandra Baldi
ORCID logo ,
Hesham R. El-Seedi
,
Shaden A. M. Khalifa
,
Gaetano Piccinocchi
,
Pietro Campiglia
ORCID logo ,
Roberto Sacchi
ORCID logo ,
Maria Daglia
* ORCID logo
Version 1 : Received: 18 May 2023 / Approved: 19 May 2023 / Online: 19 May 2023 (08:34:41 CEST)

A peer-reviewed article of this Preprint also exists.

Ullah, H.; Sommella, E.; Minno, A.D.; Piccinocchi, R.; Buccato, D.G.; Lellis, L.F.D.; Riccioni, C.; Baldi, A.; El-Seedi, H.R.; Khalifa, S.A.M.; Piccinocchi, G.; Campiglia, P.; Sacchi, R.; Daglia, M. Combination of Chemically Characterized Pomegranate Extract and Hydrophilic Vitamins against Prolonged Fatigue: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients 2023, 15, 2883. Ullah, H.; Sommella, E.; Minno, A.D.; Piccinocchi, R.; Buccato, D.G.; Lellis, L.F.D.; Riccioni, C.; Baldi, A.; El-Seedi, H.R.; Khalifa, S.A.M.; Piccinocchi, G.; Campiglia, P.; Sacchi, R.; Daglia, M. Combination of Chemically Characterized Pomegranate Extract and Hydrophilic Vitamins against Prolonged Fatigue: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients 2023, 15, 2883.

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® Response) 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 stressed conditions. This study shows that the food supplement tested reduces prolonged fatigue following two months supplementation in healthy subjects with mild prolonged fatigue.

Keywords

Prolonged fatigue; pomegranate extract; polyphenols; vitamin B complex; vitamin C

Subject

Medicine and Pharmacology, Pharmacy

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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