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Study Protocol

Cognitive, Neuropsychological and Biological Effects of Oxygen–Ozone Therapy on Frailty: A Study Protocol for a 5-Week, Randomized, Placebo-Controlled Trial

by
Catia Scassellati
1,
Cristian Bonvicini
2,*,
Miriam Ciani
3,
Roberta Zanardini
2,
Evita Tomasoni
4,
Valentina Saletti
4,
Ilaria Passeggia
4,
Monica Almici
5,
Ilaria Pagnoni
6,
Antonio Carlo Galoforo
7,
Mario Costa
8,9,
Mara D’Onofrio
10,
Antonino Cattaneo
9,10 and
Cristina Geroldi
11
1
Biological Psychiatry Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125 Brescia, Italy
2
Molecular Markers Laboratory, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125 Brescia, Italy
3
Department of Biomedical Sciences, University of Modena and Reggio Emilia, 41121 Modena, Italy
4
Laboratory Alzheimer’s Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125 Brescia, Italy
5
Clinical Trial Service, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125 Brescia, Italy
6
Neuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125 Brescia, Italy
7
Oxygen-Ozone Therapy Scientific Society (SIOOT), 24020 Gorle, Italy
8
Institute of Neuroscience, Italian National Research Council (CNR), 56124 Pisa, Italy
9
Laboratory of Biology “Bio@SNS”, Scuola Normale Superiore, 56124 Pisa, Italy
10
European Brain Research Institute (EBRI) Rita Levi-Montalcini, 00161 Rome, Italy
11
Alzheimer’s Unit—Memory Clinic, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125 Brescia, Italy
*
Author to whom correspondence should be addressed.
J. Pers. Med. 2024, 14(8), 795; https://doi.org/10.3390/jpm14080795 (registering DOI)
Submission received: 17 June 2024 / Revised: 8 July 2024 / Accepted: 25 July 2024 / Published: 27 July 2024
(This article belongs to the Section Disease Biomarker)

Abstract

Cognitive frailty (CF) is a heterogeneous syndrome that is becoming one of the most serious health problems as the world’s population age is increasing. Elucidating its biological mechanisms as well as prevention and treatments is becoming increasingly significant, particularly in view of the associated health costs. We presented the study protocol of a research project funded by the Italian Ministry of Health (grant number RF-2016-02363298) aiming to investigate the cognitive and neuropsychological effects of a 5-week treatment with therapy based on the regenerative properties of ozone (O3) in a cohort of subjects stratified according to CF scores. We also studied the potential effects of O3 on blood-based biomarkers indicative of specific biological systems that may be altered in CF. Seventy-five older persons were recruited and randomly assigned to receive the active treatment (150 cc of oxygen-O2-O3 mixture at the concentration of 30 µg of O3 per cc of O2), O2, or the placebo (air) for 5 weeks. The main endpoints were the change in the scores of clinical scales from baseline (T0) to weeks 3 (T3), 9 (T9), and 15 (T15) after treatment and the change in biomarker levels resulting from transcriptomics, proteomics, and metabolomic patterns at the same times. The positive results from this study could have important clinical implications.
Keywords: cognitive frailty; frailty; randomized double-blind clinical trial; oxygen–ozone therapy; neuropsychological markers; biological markers cognitive frailty; frailty; randomized double-blind clinical trial; oxygen–ozone therapy; neuropsychological markers; biological markers

Share and Cite

MDPI and ACS Style

Scassellati, C.; Bonvicini, C.; Ciani, M.; Zanardini, R.; Tomasoni, E.; Saletti, V.; Passeggia, I.; Almici, M.; Pagnoni, I.; Galoforo, A.C.; et al. Cognitive, Neuropsychological and Biological Effects of Oxygen–Ozone Therapy on Frailty: A Study Protocol for a 5-Week, Randomized, Placebo-Controlled Trial. J. Pers. Med. 2024, 14, 795. https://doi.org/10.3390/jpm14080795

AMA Style

Scassellati C, Bonvicini C, Ciani M, Zanardini R, Tomasoni E, Saletti V, Passeggia I, Almici M, Pagnoni I, Galoforo AC, et al. Cognitive, Neuropsychological and Biological Effects of Oxygen–Ozone Therapy on Frailty: A Study Protocol for a 5-Week, Randomized, Placebo-Controlled Trial. Journal of Personalized Medicine. 2024; 14(8):795. https://doi.org/10.3390/jpm14080795

Chicago/Turabian Style

Scassellati, Catia, Cristian Bonvicini, Miriam Ciani, Roberta Zanardini, Evita Tomasoni, Valentina Saletti, Ilaria Passeggia, Monica Almici, Ilaria Pagnoni, Antonio Carlo Galoforo, and et al. 2024. "Cognitive, Neuropsychological and Biological Effects of Oxygen–Ozone Therapy on Frailty: A Study Protocol for a 5-Week, Randomized, Placebo-Controlled Trial" Journal of Personalized Medicine 14, no. 8: 795. https://doi.org/10.3390/jpm14080795

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