Combination of Chemically Characterized Pomegranate Extract and Hydrophilic Vitamins against Prolonged Fatigue: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
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). U...
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MDPI AG
2023-06-01
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| Series: | Nutrients |
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| Online Access: | https://www.mdpi.com/2072-6643/15/13/2883 |
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| author | Hammad Ullah Eduardo Sommella Alessandro Di Minno Roberto Piccinocchi Daniele Giuseppe Buccato Lorenza Francesca De Lellis Costanza Riccioni Alessandra Baldi Hesham R. El-Seedi Shaden A. M. Khalifa Gaetano Piccinocchi Pietro Campiglia Roberto Sacchi Maria Daglia |
| author_facet | Hammad Ullah Eduardo Sommella Alessandro Di Minno Roberto Piccinocchi Daniele Giuseppe Buccato Lorenza Francesca De Lellis Costanza Riccioni Alessandra Baldi Hesham R. El-Seedi Shaden A. M. Khalifa Gaetano Piccinocchi Pietro Campiglia Roberto Sacchi Maria Daglia |
| author_sort | Hammad Ullah |
| collection | DOAJ |
| description | 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 (<i>n =</i> 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. |
| first_indexed | 2024-03-11T01:32:46Z |
| format | Article |
| id | doaj.art-ee78a2efce3a4976858dea06c72a338c |
| institution | Directory Open Access Journal |
| issn | 2072-6643 |
| language | English |
| last_indexed | 2024-03-11T01:32:46Z |
| publishDate | 2023-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Nutrients |
| spelling | doaj.art-ee78a2efce3a4976858dea06c72a338c2023-11-18T17:13:52ZengMDPI AGNutrients2072-66432023-06-011513288310.3390/nu15132883Combination of Chemically Characterized Pomegranate Extract and Hydrophilic Vitamins against Prolonged Fatigue: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical TrialHammad Ullah0Eduardo Sommella1Alessandro Di Minno2Roberto Piccinocchi3Daniele Giuseppe Buccato4Lorenza Francesca De Lellis5Costanza Riccioni6Alessandra Baldi7Hesham R. El-Seedi8Shaden A. M. Khalifa9Gaetano Piccinocchi10Pietro Campiglia11Roberto Sacchi12Maria Daglia13Department of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, ItalyDepartment of Pharmacy, University of Salerno, 84084 Fisciano, ItalyDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, ItalyLevel 1 Medical Director Anaesthesia and Resuscitation A. U. O. Luigi Vanvitelli, Via Santa Maria di Costantinopoli, 80138 Naples, ItalyDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, ItalyDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, ItalyR&D Department, Esserre Pharma Srl, 00191 Rome, ItalyDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, ItalyInternational Research Center for Food Nutrition and Safety, Jiangsu University, Zhenjiang 212013, ChinaPsychiatry and Psychology Department, Capio Saint Göran’s Hospital, Sankt Göransplan 1, 112 19 Stockholm, SwedenComegen S.c.S., Società Cooperativa Sociale di Medici di Medicina Generale, Viale Maria Bakunin 41, 80125 Naples, ItalyDepartment of Pharmacy, University of Salerno, 84084 Fisciano, ItalyApplied Statistic Unit, Department of Earth and Environmental Sciences, University of Pavia, Viale Taramelli 24, 27100 Pavia, ItalyDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, ItalyProlonged 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 (<i>n =</i> 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.https://www.mdpi.com/2072-6643/15/13/2883prolonged fatiguepomegranate extractpolyphenolsvitamin B complexvitamin C |
| spellingShingle | Hammad Ullah Eduardo Sommella Alessandro Di Minno Roberto Piccinocchi Daniele Giuseppe Buccato Lorenza Francesca De Lellis Costanza Riccioni Alessandra Baldi Hesham R. El-Seedi Shaden A. M. Khalifa Gaetano Piccinocchi Pietro Campiglia Roberto Sacchi Maria Daglia Combination of Chemically Characterized Pomegranate Extract and Hydrophilic Vitamins against Prolonged Fatigue: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Nutrients prolonged fatigue pomegranate extract polyphenols vitamin B complex vitamin C |
| title | Combination of Chemically Characterized Pomegranate Extract and Hydrophilic Vitamins against Prolonged Fatigue: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial |
| title_full | Combination of Chemically Characterized Pomegranate Extract and Hydrophilic Vitamins against Prolonged Fatigue: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial |
| title_fullStr | Combination of Chemically Characterized Pomegranate Extract and Hydrophilic Vitamins against Prolonged Fatigue: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial |
| title_full_unstemmed | Combination of Chemically Characterized Pomegranate Extract and Hydrophilic Vitamins against Prolonged Fatigue: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial |
| title_short | Combination of Chemically Characterized Pomegranate Extract and Hydrophilic Vitamins against Prolonged Fatigue: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial |
| title_sort | combination of chemically characterized pomegranate extract and hydrophilic vitamins against prolonged fatigue a monocentric randomized double blind placebo controlled clinical trial |
| topic | prolonged fatigue pomegranate extract polyphenols vitamin B complex vitamin C |
| url | https://www.mdpi.com/2072-6643/15/13/2883 |
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