Efficacy of Prebiotic and Probiotic Dietary Modulation in Schizophrenic Disorders

Summary

The microbiota plays a vital role in the two-way communication between the gastrointestinal tract and the central nervous system (CNS), articulated as the microbiota-intestine-brain axis. This function provides sufficient evidence to establish a causal relationship between numerous neuropsychiatric disorders, such as schizophrenia. Besides, the microbiota modulation through the dietary pattern is related to the improvement of the physical and psychopathological health of patients. In this sense, the use of psychobiotics (prebiotics and probiotics with nutraceutical action) highlights. This research will be aimed to test the efficacy of prebiotic dietary modulation in patients diagnosed with schizophrenia, attending to the impact in nutritional and cardio-metabolic conditions. In this sense, two-arms, double-blind, randomized in balanced blocks clinical trial of six months of intervention, will be developed in a group of 50 individuals (25 for the intervention group (IG) and 25 for the control group). First, an initial group session will be held to present the purpose of the research, as well as each of the relevant aspects during its development. Similarly, certain focus groups will be established periodically to redefine and guide the improvement of the development of the investigation, ensuring adequate compliance with the study after the implementation of the diet and nutrition education program. The dietary education will be designed and supervised by qualified personnel with recognized competencies for this type of intervention (nurses and dietitians). The CG will be made up of those participants who receive conventional dietary advice individually in serial consultations. On the other hand, in the IG, this intervention will be characterized by the establishment of an individual program of dietetic-nutritional education with high prebiotic and probiotic content. During the development of the study, data will be collected on the psychopathological state (PANSS and PSP scales), and blood test (hemogram, lipid profile, etc.). Measures will be taken at the beginning (basal), at three and six months. The estimation of intestinal microbiota and the usual nutritional pattern will also be assessed at the beginning and six months, using a stool test and a validated Food Frequency Questionnaire (FFQ), respectively. To evaluate the degree of adherence, participants in the IG will fill a specific weekly record of the main dishes/food consumed. At least, anthropometric parameters will also be analyzed monthly (BMI, blood pressure, heart rate, abdominal perimeter).

Conditions

• Schizophrenia and Related Disorders
• Diet Habit

Interventions

BEHAVIORAL

Conventional Dietary Advice

The education content in the control group will be centered on the acquisition of knowledge about: * \- Underlying mental pathology, lifestyles and associated comorbidities * \- Immediate principles: Carbohydrates, lipids, proteins, fiber, vitamins, and minerals; energy needs; consumption requirements. * \- Water requirements. * \- Foodstuffs. * \- Culinary techniques: conservation of properties of the diet. * \- Feeding in particular situations.

BEHAVIORAL

Prebiotic/Probiotic Dietary Modulation

The education content in the intervention group will be based on general principles of conventional dietary advice in an intensified manner, centered on the acquisition of specific knowledge about: * \- Underlying mental pathology, lifestyles and associated comorbidities * \- Immediate principles: Carbohydrates, lipids, proteins, fiber, vitamins, and minerals; energy needs; consumption requirements. * \- Water requirements. * \- Foodstuffs. * \- Description and justification of prescribed prebiotic and probiotic diet. * \- Culinary techniques: conservation of properties of the prebiotic and probiotic diet. * \- Optimal distribution and interchange of foods with high prebiotic and probiotic content. * \- Feeding in particular situations.

Sponsors & Collaborators

• Castilla-León Health Service

  collaborator OTHER

• Universidad de Córdoba

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-25

Primary Completion

2021-10-19

Completion

2023-12-26

Countries

• Spain

Study Locations