Background The development of new aetiological premises, such as the microbiota-gut-brain axis theory, evidences the influence of dietary and nutritional patterns on mental health, affecting the patient's quality of life in terms of physical and cardiovascular health. The aim was to determine the impact of a nutritional programme focused on increasing the intake of prebiotic and probiotic food on cardio-metabolic status in individuals with schizophrenia spectrum disorders in the contextual setting of the SARS-CoV-2 era. Methods A randomised clinical trial (two-arm, double-blind, balanced-block, six-month intervention) was conducted in a group of 50 individuals diagnosed with schizophrenia spectrum disorder during the SARS-CoV-2 confinement period. The control group received conventional dietary counselling on an individual basis. In the intervention group, an individual nutritional education programme with a high content of prebiotics and probiotics (dairy and fermented foods, green leafy vegetables, high-fibre fruit, whole grains, etc.) was established. Data on cardiovascular status were collected at baseline, three and six months. In addition, anthropometric parameters were analysed monthly. Results Forty-four subjects completed follow-up and were analysed. Statistical differences (p < 0.05) were found in all anthropometric variables at baseline and six months of intervention. A 27.4% reduction in the prevalence of metabolic syndrome risk factors in all its components was evidenced, leading to a clinically significant improvement (decrease in cardiovascular risk) in the intervention group at six months. Conclusions The development of a nutritional programme focused on increasing the dietary content of prebiotics and probiotics effectively improves the cardio-metabolic profile in schizophrenia spectrum disorders. Therefore, nursing assumes an essential role in the effectiveness of dietary interventions through nutritional education and the promotion of healthy lifestyles. Likewise, nursing acquires a relevant role in interdisciplinary coordination in confinement contexts. Trial registration The study protocol complied with the Declaration of Helsinki for medical studies; the study received ethical approval from referral Research Ethics Committee in November 2019 (reg. no. 468) and retrospectively registered in clinicaltrials.gov (NCT04366401. First Submitted: 28th April 2020; First Registration: 25th June 2020).

Background/ObjectivesThe microbiota plays a vital role in the two-way communication between the gastrointestinal tract and numerous neuropsychiatric disorders, such as schizophrenia. Besides, the microbiota modulation through the use of psychobiotics (prebiotics and probiotics with nutraceutical action) is related to the improvement of the physical and psychopathological health. The objective to this study was to test the efficacy of prebiotic/probiotic dietary modulation in patients diagnosed with schizophrenia, attending to the nutritional and cardio-metabolic impact.MethodsTwo-arms, double-blind, randomized in balanced blocks clinical trial of 6 months of intervention, will be developed in a group of 50 individuals. The control group will receive conventional dietary advice individually from specialized mental health nurses. In the intervention group, an individual dietetic-nutritional education program with high prebiotic and probiotic content (dairy and fermented foods, green leafy vegetables, high-fiber fruit, whole grains, etc.) will be developed by these nurses. Data will be collected on the psychopathological state, and blood test (at the beginning, at 3 and 6 months). The estimation of intestinal microbiota and the usual nutritional pattern will also be assessed at the beginning and 6 months, using a stool test. To evaluate the degree of adherence, the intervention group will fill a specific weekly record of the main dishes/food consumed. Anthropometric parameters will also be analyzed monthly.DiscussionThe study is anticipated to establish feasibility an adequate dietary modulation with a high simbiotic content, leads to a significant improvement in the nutritional status and cardio-metabolic. Furthermore, it is presumed to reach a degree of evidence that allows establishing nutritional management as an effective therapeutic intervention in the psychopathological treatment of patients with schizophrenia spectrum disorders.Clinical Trial Registration[www.ClinicalTrials.gov], identifier [NCT04366401].