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

Author:

Scassellati Catia1,Bonvicini Cristian2ORCID,Ciani Miriam3,Zanardini Roberta2ORCID,Tomasoni Evita4,Saletti Valentina4,Passeggia Ilaria4,Almici Monica5ORCID,Pagnoni Ilaria6,Galoforo Antonio Carlo7,Costa Mario89ORCID,D’Onofrio Mara10,Cattaneo Antonino910,Geroldi Cristina11

Affiliation:

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

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.

Funder

Italian Ministry of Health

Publisher

MDPI AG

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