Efficacy of Dietary Modulation With High Prebiotic and Probiotic Content on Nutritional and Metabolic Status in Schizophrenia Spectrum Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Changes in Clinical Efficacy of Prebiotic/Probiotic Dietary Modulation in 6 Months of Intervention
研究概览
简要总结
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).
详细描述
- INTRODUCTION
1.1. Theoretical Framework
Schizophrenia is a chronic mental illness characterized by significant clinical heterogeneity and a long evolution over time, determined by periods of psychotic exacerbation and phases of stabilization. The semiology of this nosological entity is established in positive and negative symptoms, with variable levels of dysfunction and clinical presentation, and having an essential impact on the patient's quality of life. Similarly, surrounding the schizophrenic spectrum, the existence of the associated neurocognitive impairment stands out, prevailing the disorders of social and occupational functioning, as well as a significant degree of disorganization.
Many theories have tried to elucidate the origin of schizophrenia, where the complexity of its etiopathogenesis is a determining factor in establishing an appropriate, specific, and effective therapeutic approach. However, despite numerous defined aetiological premises, the dopaminergic hypothesis is considered the final common pathway of all of them, converging numerous associated pathogenic mechanisms, where low-grade systemic inflammation and oxidative stress stand out.
Undoubtedly, the traditional therapeutic approach has perceived the role of nutrition as a minor intervention in psychiatry, especially in psychotic disorders such as schizophrenia. However, the advances established in the last decade, mainly associated with the development of the holobionte theory and the evolution of metagenomics, as well as the presence of new dietary patterns of low nutritional quality in different western societies, have contributed significantly to the global understanding of the role of nutritional patterns on the functioning of the Central Nervous System (CNS), as well as on the possible mechanisms or etiological pathways of psychiatric disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-Patients diagnosed on the spectrum of schizophrenia (without distinction by type), according to criteria DSM-5 and/or ICD-
- •Age between 18-65 years.
- •- Absence of gastrointestinal comorbidity that contraindicates the use of prebiotics and/or probiotics (intolerance, explosive diarrhea, acute abdominal pain, etc.).
- •-To show clinical stability for six months before the start of the study (absence of psychiatric hospitalization, maintenance of the level of functionality, and lack of social and occupational absenteeism).
- •- To manifest agreement to participate in the study and to sign of informed consent.
排除标准
- •-Non-compliance with the inclusion criteria mentioned above.
- •- To suffer from somatic or neurocognitive situation that prevents participation and collaboration in the fulfillment of the protocol.
- •- To follow standardized dietary planning not modulated by the population under study (catering, institutional or collective feeding, etc.).
- •-Concomitant administration of antibiotherapy.
- •Refusal to participate in the study.
结局指标
主要结局
Changes in Clinical Efficacy of Prebiotic/Probiotic Dietary Modulation in 6 Months of Intervention
时间窗: Basal, three and six months respectively
\-- Personal and Social Functioning Scale (categorized PSP) outcome: discrete. Scoring interval (range 10 points: 0-100) in relation to the degree of dysfunction of the areas: self-care, personal and social relationships, socially functional activities (work/study), disturbing and aggressive behaviour. To establish the final decimal point of this interval, 10 functional aspects must be scored (YES: 1 point, NO: 0 points). Finally, the higher the score, the better the patient's functional level.
Changes in Adherence to the Proposed Dietary Pattern in 6 Months of Intervention
时间窗: Basal and six months respectively
\-- Food Consumption Frequency Questionnaire (CFCA) result: continuous. For the proper analysis of this document, it is necessary to transform the answers obtained from the Food Consumption Frequency Questionnaire -FCA- into the number of times each item was consumed per week and into the number of times it was consumed per day. The g/day was then calculated by multiplying the frequencies of consumption of each item by the weight of the usual consumption ration of each item (Weight of Ration of Items table -PRI-). Finally, the energy and nutritional value was calculated by applying the Adapted Food Composition table (AFC): first the consumption in the population of all the foods included in each item was added; then, the proportion of this total provided by each of these foods was calculated
Improvement on Cardiometabolic Profile
时间窗: Every month, during 6 months of intervention
\- Weight (kg, continuous).
Changes in Blood Test Variables in 6 Months of Intervention
时间窗: Basal, three and six months respectively
\-- Haematological profile: Red blood cells (x10e6/mm3, continuous).
Changes in Other Biochemical Parameters
时间窗: Basal, three and six months respectively
\- Biochemical profile: ALT/GPT (IU/L, discrete), G-GT (IU/L, discrete), FAL (IU/L, discrete) a-HBs (UI/L, continuous), LUES (UI/L, nominal/discrete), a-HAV-M (UI/L, nominal/discrete), a-HCV (UI/L, nominal/discrete), HBsAg (UI/L, nominal/discrete), a-HBC-IgG (UI/L, nominal/discrete).
Changes in Stool Culture in 6 Months of Intervention
时间窗: Basal and six months respectively
\-- Stool Culture: General bacteriology - Usual mixed flora/disbiosis: Salmonella spp (nominal), Shigella spp (nominal), Yersinia spp (nominal), Hafnia alvei (nominal), Aermonas spp (nominal), Campylobacter spp (nominal) -.
次要结局
未报告次要终点
研究者
Alfonso Sevillano Jiménez
Registered Nurse, Psychiatric-Mental Health Nurse Practitioner, Master Of Science, Doctoral Student
Universidad de Córdoba