Efficacy of nutrition education for the increase of symbiotic intake on nutritional and metabolic status in schizophrenic spectrum disorders: A two-arm protocol

BACKGROUND/OBJECTIVES: The 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. METHODS: Two-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. DISCUSSION: The 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].