Efficacy of Prebiotic and Probiotic Dietary Modulation in Schizophrenic Disorders

NCT04366401 | Completed

• 1 other identifier: UC-Psychobiotics2020
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prebiotic; Probiotic; Schizophrenia Spectrum and Other Psychotic Disorders; Diet Therapy

Outcome Measures

Primary Outcomes (33)

• Changes in Clinical Efficacy of Prebiotic/Probiotic Dietary Modulation in 6 Months of Intervention

  \-- 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.

  Basal, three and six months respectively

• Changes in Clinical Efficacy of Prebiotic/Probiotic Dietary Modulation in 6 Months of Intervention

  \-- Scale for Positive and Negative Schizophrenia Syndrome (categorized PANSS): discrete. It provides four dimensional scores: Positive syndrome, Negative syndrome, Compound scale, General psychopathology. The score on the positive (PANSS-P) is obtained by adding up the scores of each item. The scores will therefore range from 7 to 49 for the positive scale.. There are no cut-off points for the direct scores obtained, but these are transformed by means of a conversion table into percentiles. Futhermore, PANSS also provides categorical information, indicating whether the schizophrenic disorder is positive, negative or mixed.

  Basal, three and six months respectively

• Changes in Clinical Efficacy of Prebiotic/Probiotic Dietary Modulation in 6 Months of Intervention

  \-- Scale for Positive and Negative Schizophrenia Syndrome (categorized PANSS): discrete. It provides four dimensional scores: Positive syndrome, Negative syndrome, Compound scale, General psychopathology. The score on the negative (PANSS-N) is obtained by adding up the scores of each item. The scores will therefore range from 7 to 49 for the negative scale.. There are no cut-off points for the direct scores obtained, but these are transformed by means of a conversion table into percentiles. Futhermore, PANSS also provides categorical information, indicating whether the schizophrenic disorder is positive, negative or mixed.

  Basal, three and six months respectively

• Changes in Clinical Efficacy of Prebiotic/Probiotic Dietary Modulation in 6 Months of Intervention

  \-- Scale for Positive and Negative Schizophrenia Syndrome (categorized PANSS): discrete. It provides four dimensional scores: Positive syndrome, Negative syndrome, Compound scale, General psychopathology. The score on the general psychopathology (PANSS-PG) scale is obtained by adding up the scores of each item. The scores will therefore rangd from 16 to 112 for the general psychopathology. There are no cut-off points for the direct scores obtained, but these are transformed by means of a conversion table into percentiles. Futhermore, PANSS also provides categorical information, indicating whether the schizophrenic disorder is positive, negative or mixed.

  Basal, three and six months respectively

• Changes in Clinical Efficacy of Prebiotic/Probiotic Dietary Modulation in 6 Months of Intervention

  \-- Scale for Positive and Negative Schizophrenia Syndrome (categorized PANSS): discrete. It provides four dimensional scores: Positive syndrome, Negative syndrome, Compound scale, General psychopathology. The score on the composite scale (PANNS-C) is obtained by subtracting the score on the negative scale from the score on the positive scale. This scale can have positive or negative valence, ranging from -42 to + 42. There are no cut-off points for the direct scores obtained, but these are transformed by means of a conversion table into percentiles. Futhermore, PANSS also provides categorical information, indicating whether the schizophrenic disorder is positive, negative or mixed.

  Basal, three and six months respectively

• Changes in Adherence to the Proposed Dietary Pattern in 6 Months of Intervention

  \-- 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

  Basal and six months respectively

• Improvement on Cardiometabolic Profile

  \- Weight (kg, continuous).

  Every month, during 6 months of intervention

• Improvement on Cardiometabolic Profile

  \- Height (cm, continuous), circumference (cm, continuous).

  Every month, during 6 months of intervention

• Improvement on Cardiometabolic Profile

  \- BMI: Weight and height will be combined to report BMI in kg/m\^2 (continous).

  Every month, during 6 months of intervention

• Improvement on Cardiometabolic Profile

  \- Systolic blood pressure (mmHg, continuous), diastolic blood pressure (mmHg, continuous).

  Every month, during 6 months of intervention

• Improvement on Cardiometabolic Profile

  \- Heart rate (ppm, discrete).

  Every month, during 6 months of intervention

• Improvement on Cardiometabolic Profile

  \- Biochemical profile: glucose (mg/dL, discrete), cholesterol (mg/dL, discrete), triglycerides (mg/dL, discrete), C-HDL (mg/dL, discrete), C-LDL (mg/dL, discrete), total cholesterol/C-HDL (mg/dL, discrete).

  Every month, during 6 months of intervention

• Improvement on Cardiometabolic Profile

  \- Biochemical profile: LDH (IU/L, discrete).

  Every month, during 6 months of intervention

• Changes in Blood Test Variables in 6 Months of Intervention

  \-- Haematological profile: Red blood cells (x10e6/mm3, continuous).

  Basal, three and six months respectively

• Changes in Blood Test Variables in 6 Months of Intervention

  \-- Haematological profile: Haemoglobin (g/dL, continuous), C.H.C.M. (g/dL, discrete).

  Basal, three and six months respectively

• Changes in Blood Test Variables in 6 Months of Intervention

  \-- Haematological profile: Haematocrit (%, continuous), R.D.W (%, continuous)..

  Basal, three and six months respectively

• Changes in Blood Test Variables in 6 Months of Intervention

  \-- Haematological profile: M.C.V. (fL, discrete), M.P.V. (fL, discrete).

  Basal, three and six months respectively

• Changes in Blood Test Variables in 6 Months of Intervention

  \-- Haematological profile: H.C.M. (pg ,discrete).

  Basal, three and six months respectively

• Changes in Blood Test Variables in 6 Months of Intervention

  \-- Haematological profile: Leukocytes (x10e3/mm3, discrete).

  Basal, three and six months respectively

• Changes in Blood Test Variables in 6 Months of Intervention

  \-- Haematological profile: Neutrophils (x10e3/m, continuous), lymphocytes (x10e3/m, continuous), monocytes (x10e3/m, continuous), eosinophils (x10e3/m, continuous), basophils (x10e3/m, continuous), platelets (x10e3/mm3, discrete).

  Basal, three and six months respectively

• Changes in Other Biochemical Parameters

  \- 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).

  Basal, three and six months respectively

• Changes in Other Biochemical Parameters

  \- Biochemical profile: Na+/K+ (mEq/L, discrete/continuous, respectively), Cl- (mEq/L, continuous), Ca2+ (mEq/L, continuous).

  Basal, three and six months respectively

• Changes in Other Biochemical Parameters

  \- Biochemical profile: Urate (mg/dL, continuous), creatinine (mg/dL, continuous).

  Basal, three and six months respectively

• Changes in Other Biochemical Parameters

  \- Biochemical profile: HbA1c (%, continuous).

  Basal, three and six months respectively

• Changes in Other Biochemical Parameters

  \- Biochemical profile: HbA1c IFCC (mmol/mol, continuous).

  Basal, three and six months respectively

• Changes in Other Biochemical Parameters

  \- Biochemical profile: Fructosamine (mcmol/L, discrete).

  Basal, three and six months respectively

• Changes in Other Biochemical Parameters

  \- Biochemical profile: Fe2+ (mcg/dL, discrete), FRT (mcg/dL, discrete), folate (mcg/dL, continuous).

  Basal, three and six months respectively

• Changes in Other Biochemical Parameters

  \- Biochemical profile:Vit.B12 (ng/mL, discrete), vit.D total (D2+D3) 25-OH (ng/mL, discrete).

  Basal, three and six months respectively

• Changes in Other Biochemical Parameters

  \- Biochemical profile: Glomerular filtrate estimation (mL/min/1,73 m\^2, discrete).

  Basal, three and six months respectively

• Changes in Other Biochemical Parameters

  \- Biochemical profile: TSH (mU/L, continuous).

  Basal, three and six months respectively

• Changes in Other Biochemical Parameters

  \- Biochemical profile: PRL (ng/dL, continuous).

  Basal, three and six months respectively

• Changes in Other Biochemical Parameters

  \- Biochemical profile: Na+/K+ (mEq/L, discrete/continuous, respectively), Cl- (mEq/L, continuous), Ca2+ (mEq/L, continuous),

  Basal, three and six months respectively

• Changes in Stool Culture in 6 Months of Intervention

  \-- 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) -.

  Basal and six months respectively

Study Arms (2)

Conventional Dietary Advice

ACTIVE COMPARATOR

The control group will consist of participants diagnosed on the schizophrenic spectrum who will receive conventional dietary counseling (n=25) on an individual basis. In the control group, data will be collected on the psychopathological state (PANSS and PSP scales), and blood analysis (hemogram, lipid profile, etc.). The measurements will be taken at the beginning (basal), at three and six months. The estimation of the intestinal microbiota and the usual nutritional pattern will also be evaluated at the beginning and at six months, using a stool test and a validated food frequency questionnaire, respectively. To assess the degree of adherence, GI participants will fill in a specific weekly record of the main dishes/foods consumed. At least, anthropometric parameters will also be analysed monthly (BMI, blood pressure, heart rate, abdominal perimeter).

Behavioral: Conventional Dietary Advice

Prebiotic/Probiotic Dietary Modulation

EXPERIMENTAL

In the intervention group (n=25), individual dietary counseling will be established through intensive nutritional counseling to provide a high prebiotic and probiotic food pattern. In the experimental group, data will be collected on psychopathological status (Positive and Negative Syndrome Scale -PANSS- and Personal and Social Functioning Scale -PSP-), and blood tests (haemogram, lipid profile, etc.). The measurements will be taken at the beginning (basal), at three and six months. The estimation of the intestinal microbiota and the usual nutritional pattern will also be evaluated at the beginning and at six months, using a stool test and a validated food frequency questionnaire, respectively. To assess the degree of adherence, GI participants will fill in a specific weekly record of the main dishes/foods consumed. At least, anthropometric parameters will also be analysed monthly (BMI, blood pressure, heart rate, abdominal perimeter).

Behavioral: Prebiotic/Probiotic Dietary Modulation

Interventions

Conventional Dietary Advice BEHAVIORAL

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.

Conventional Dietary Advice

Prebiotic/Probiotic Dietary Modulation BEHAVIORAL

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.

Prebiotic/Probiotic Dietary Modulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed on the spectrum of schizophrenia (without distinction by type), according to criteria DSM-5 and/or ICD-11.
• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Universidad de Córdoba: lead
• Castilla-León Health Service: collaborator

Study Sites (1)

Universidad de Córdoba.

Córdoba, 14071, Spain

Location

Related Publications (45)

• Balanza Martinez V. Nutritional supplements in psychotic disorders. Actas Esp Psiquiatr. 2017 Sep;45(Supplement):16-25. Epub 2017 Sep 1.

  PMID: 29171643 BACKGROUND

• American Psychiatric Association. Manual diagnóstico y estadístico de los trastornos mentales: DSM-5. Madrid: Editorial Médica Panamericana;2014.

  BACKGROUND

• Gómez AE. Nutrición y enfermedad mental. Esquizofrenia y ácidos grasos omega 3. Farmacia Profesional. 2007;21(3):60-63

  BACKGROUND

• Bernardo M, Canas F, Herrera B, Garcia Dorado M. Adherence predicts symptomatic and psychosocial remission in schizophrenia: Naturalistic study of patient integration in the community. Rev Psiquiatr Salud Ment. 2017 Jul-Sep;10(3):149-159. doi: 10.1016/j.rpsm.2016.04.001. Epub 2016 Jun 10. English, Spanish.

  PMID: 27291833 BACKGROUND

• Tandon R, Nasrallah HA, Keshavan MS. Schizophrenia, "just the facts" 4. Clinical features and conceptualization. Schizophr Res. 2009 May;110(1-3):1-23. doi: 10.1016/j.schres.2009.03.005. Epub 2009 Mar 27.

  PMID: 19328655 BACKGROUND

• Godoy JF, Caballero M, Godoy-Izquierdo D, Vázquez ML, Muela JA. Prevención de recaídas en la esquizofrenia: propuesta de un programa de intervención durante la fase prodrómica. Rei Do Crea. 2016;Vol.5(1):56-58. DOI 10.1016 / j.rcp.2015.05.011

  BACKGROUND

• Soria V, Uribe J, Salvat-Pujol N, Palao D, Menchon JM, Labad J. Psychoneuroimmunology of mental disorders. Rev Psiquiatr Salud Ment (Engl Ed). 2018 Apr-Jun;11(2):115-124. doi: 10.1016/j.rpsm.2017.07.006. Epub 2017 Oct 6. English, Spanish.

  PMID: 28993125 BACKGROUND

• Cepeda V, Mondragón A, Lamas A, Miranda JM, Cepeda A. Empleo de prebióticos y probióticos en el manejo de la ansiedad. Farmaceut Comunit. 2019;11(2):30-40. DOI:10.5672/FC.2173-9218

  BACKGROUND

• Icaza-Chavez ME. [Gut microbiota in health and disease]. Rev Gastroenterol Mex. 2013 Oct-Dec;78(4):240-8. doi: 10.1016/j.rgmx.2013.04.004. Epub 2013 Nov 28. Spanish.

  PMID: 24290319 BACKGROUND

• Castillo-Alvarez F, Marzo-Sola ME. Role of the gut microbiota in the development of various neurological diseases. Neurologia (Engl Ed). 2022 Jul-Aug;37(6):492-498. doi: 10.1016/j.nrl.2019.03.017. Epub 2019 Jul 21. English, Spanish.

  PMID: 31340904 BACKGROUND

• Rodríguez A, Solano M. Nutrición y salud mental: revisión bibliográfica. Rev Post Psiquiat UNAH. 2008;1(3):1-5.

  BACKGROUND

• Salagre E, Vieta E, Grande I. The visceral brain: Bipolar disorder and microbiota. Rev Psiquiatr Salud Ment. 2017 Apr-Jun;10(2):67-69. doi: 10.1016/j.rpsm.2017.02.001. Epub 2017 Mar 22. No abstract available. English, Spanish.

  PMID: 28341435 BACKGROUND

• Wang HX, Wang YP. Gut Microbiota-brain Axis. Chin Med J (Engl). 2016 Oct 5;129(19):2373-80. doi: 10.4103/0366-6999.190667.

  PMID: 27647198 BACKGROUND

• Mariño A, Núñez M, Barreto J. Microbiota, probióticos, prebióticos y simbióticos. Pediatr Integral. 2015; 19(5):337-354.

  BACKGROUND

• Andreo P, García N, Sánchez EP. La microbiota intestinal y su relación con las enfermedades mentales a través del eje microbiota-intestino-cerebro. Rev Dis Cli Neuro. 2017;4(2):52-58.

  BACKGROUND

• Kim YK, Shin C. The Microbiota-Gut-Brain Axis in Neuropsychiatric Disorders: Pathophysiological Mechanisms and Novel Treatments. Curr Neuropharmacol. 2018;16(5):559-573. doi: 10.2174/1570159X15666170915141036.

  PMID: 28925886 BACKGROUND

• Patra S. Psychobiotics: A paradigm shift in psychopharmacology. Indian J Pharmacol. 2016 Jul-Aug;48(4):469-470. doi: 10.4103/0253-7613.186194. No abstract available.

  PMID: 27756969 BACKGROUND

• Sarkar A, Lehto SM, Harty S, Dinan TG, Cryan JF, Burnet PWJ. Psychobiotics and the Manipulation of Bacteria-Gut-Brain Signals. Trends Neurosci. 2016 Nov;39(11):763-781. doi: 10.1016/j.tins.2016.09.002. Epub 2016 Oct 25.

  PMID: 27793434 BACKGROUND

• Kali A. Psychobiotics: An emerging probiotic in psychiatric practice. Biomed J. 2016 Jun;39(3):223-4. doi: 10.1016/j.bj.2015.11.004. Epub 2016 Aug 9.

  PMID: 27621125 BACKGROUND

• Forsythe P, Kunze W, Bienenstock J. Moody microbes or fecal phrenology: what do we know about the microbiota-gut-brain axis? BMC Med. 2016 Apr 19;14:58. doi: 10.1186/s12916-016-0604-8.

  PMID: 27090095 BACKGROUND

• Galletero JM. Nutrición y enfermedad mental. Marcadores bioquímicos en el trastorno bipolar. Zainak. 2011;34:323-334

  BACKGROUND

• Franch CM, Molina V, Franch JI. Factores determinantes del riesgo metabólico en el tratamiento con antipsicóticos atípicos. Rev Psiquiatr Salud Ment. 2016;23(3):87-130. DOI: 10.1016/j.psiq.2016.08.001

  BACKGROUND

• Franch Pato CM, Molina Rodriguez V, Franch Valverde JI. Metabolic syndrome and atypical antipsychotics: Possibility of prediction and control. Rev Psiquiatr Salud Ment. 2017 Jan-Mar;10(1):38-44. doi: 10.1016/j.rpsm.2016.09.003. Epub 2016 Dec 7. English, Spanish.

  PMID: 27939025 BACKGROUND

• Sánchez ML, González J, Martínez MC. Control metabólico y prolactina en la enfermedad mental grave. Intervenciones enfermeras. Rev Enferm Salud Ment. 2018;9:24-28. DOI: 10.5538/2385-703X.2018.9.24

  BACKGROUND

• Pringsheim T, Kelly M, Urness D, Teehan M, Ismail Z, Gardner D. Physical Health and Drug Safety in Individuals with Schizophrenia. Can J Psychiatry. 2017 Sep;62(9):673-683. doi: 10.1177/0706743717719898. Epub 2017 Jul 18.

  PMID: 28718324 BACKGROUND

• Pina-Camacho L, Diaz-Caneja CM, Saiz PA, Bobes J, Corripio I, Grasa E, Rodriguez-Jimenez R, Fernandez M, Sanjuan J, Garcia-Lopez A, Tapia-Casellas C, Alvarez-Blazquez M, Fraguas D, Mitjans M, Arias B, Arango C. Pharmacogenetic study of second-generation antipsychotic long-term treatment metabolic side effects (the SLiM Study): rationale, objectives, design and sample description. Rev Psiquiatr Salud Ment. 2014 Oct-Dec;7(4):166-78. doi: 10.1016/j.rpsm.2014.05.004. Epub 2014 Oct 19. English, Spanish.

  PMID: 25440735 BACKGROUND

• Severi E, Ferrara M, Tedeschini E, Vacca F, Mungai F, Amendolara R, Baccari F, Starace F. Assessment of cardiovascular risk in an Italian psychiatric outpatient sample: A chart review of patients treated with second-generation antipsychotics. Int J Ment Health Nurs. 2018 Jun;27(3):1002-1008. doi: 10.1111/inm.12407. Epub 2017 Dec 2.

  PMID: 29197134 BACKGROUND

• Ocando L, Roa A, León M, González R. Antipsicóticos atípicos y su papel en el desarrollo de enfermedades metabólicas. Rev Iberoam Hipert. 2018;13(2):44-51.

  BACKGROUND

• Gurusamy J, Gandhi S, Damodharan D, Ganesan V, Palaniappan M. Exercise, diet and educational interventions for metabolic syndrome in persons with schizophrenia: A systematic review. Asian J Psychiatr. 2018 Aug;36:73-85. doi: 10.1016/j.ajp.2018.06.018. Epub 2018 Jun 30.

  PMID: 29990631 BACKGROUND

• Cortés B. Síndrome metabólico y antipsicóticos de segunda generación. Rev Asoc Esp Neuropsiq. 2011;31(110):303-320. DOI: 10.4321/S0211-57352011000200009

  BACKGROUND

• Gonzalez Jimenez E. Obesity: etiologic and pathophysiological analysis. Endocrinol Nutr. 2013 Jan;60(1):17-24. doi: 10.1016/j.endonu.2012.03.006. Epub 2012 May 22. English, Spanish.

  PMID: 22622157 BACKGROUND

• Chee GL, Wynaden D, Heslop K. Improving metabolic monitoring rate for young people aged 35 and younger taking antipsychotic medications to treat a psychosis: A literature review. Arch Psychiatr Nurs. 2017 Dec;31(6):624-633. doi: 10.1016/j.apnu.2017.09.002. Epub 2017 Sep 6.

  PMID: 29179831 BACKGROUND

• Sanchez-Martinez V, Romero-Rubio D, Abad-Perez MJ, Descalzo-Cabades MA, Alonso-Gutierrez S, Salazar-Fraile J, Montagud V, Facila L. Metabolic Syndrome and Cardiovascular Risk in People Treated with Long-Acting Injectable Antipsychotics. Endocr Metab Immune Disord Drug Targets. 2018;18(4):379-387. doi: 10.2174/1871530317666171120151201.

  PMID: 29165095 BACKGROUND

• Pérez BY, Jasso JA, López MM. Evaluación del estado nutricio en pacientes con trastornos psiquiátricos en una unidad hospitalaria. Nutr Clín Diet Hosp. 2017; 37(1):24-33. DOI: 10.12873/371brendayadira

  BACKGROUND

• Consejería de Salud. Consejo Dietético en Atención Primaria. Plan para la Promoción de la Salud Física y la Alimentación Equilibrada 2004-2008. Consejería de Salud. Junta de Andalucía; 2010. [Internet]. 2010. [access 6 november 2019]. Available from: https://www.juntadeandalucia.es/organismos/saludyfamilias/areas/saludvida/adulta/paginas/conscon-dietetico.html

  BACKGROUND

• Consejería de Salud. Guía de Consejo Dietético Intensivo en Atención Primaria. Plan para la Promoción de la Salud Física y la Alimentación Equilibrada 2004-2008. Consejería de Salud. Junta de Andalucía; 2007. [Internet]. 2007. [access 10 november 2019]. Available from: https://www.juntadeandalucia.es/organismos/saludyfamilias/areas/saludvida/adulta/paginas/consejo-dietetico.html

  BACKGROUND

• Agencia Española de Seguridad Alimentaria y Nutrición (AESAN) [sede Web]. Madrid: AECOSAN; 2015- [updated 12 november 2019; access el 14 november 2019]. Available from: http://www.aecosan.msssi.gob.es/AECOSAN/web/home/aecosan_inicio.htm

  BACKGROUND

• Hamui A, Varela M. La técnica de grupos focales. Inv Ed Med. 2013; 2(1):55-60. DOI: 10.1016/S2007-5057(13)72683-8

  BACKGROUND

• Martin-Moreno JM, Boyle P, Gorgojo L, Maisonneuve P, Fernandez-Rodriguez JC, Salvini S, Willett WC. Development and validation of a food frequency questionnaire in Spain. Int J Epidemiol. 1993 Jun;22(3):512-9. doi: 10.1093/ije/22.3.512.

  PMID: 8359969 BACKGROUND

• Junta de Andalucía. Instrumento de evaluación nº 8: Detección e intervención temprana en las psicosis. Escala para el síndrome positivo y negativo de la esquizofrenia (PANSS). Servicio Andaluz de Salud; 2010. [Internet]. 2010. [access 5 november 2019]. Available from: http://http://www.sspa.juntadeandalucia.es/servicioandaluzdesalud/publicaciones/listadodetalle.asp?idp=433

  BACKGROUND

• Garcia-Portilla MP, Saiz PA, Bousono M, Bascaran MT, Guzman-Quilo C, Bobes J; en nombre del grupo de validacion de la version espanola de la escala de Funcionamiento Personal y Social (PSP). Validation of the Spanish Personal and Social Performance scale (PSP) in outpatients with stable and unstable schizophrenia. Rev Psiquiatr Salud Ment. 2011 Jan;4(1):9-18. doi: 10.1016/j.rpsm.2010.11.003. Epub 2011 Mar 10. English, Spanish.

  PMID: 23446097 BACKGROUND

• Sugawara N, Sagae T, Yasui-Furukori N, Yamazaki M, Shimoda K, Mori T, Sugai T, Matsuda H, Suzuki Y, Ozeki Y, Okamoto K, Someya T. Effects of nutritional education on weight change and metabolic abnormalities among patients with schizophrenia in Japan: A randomized controlled trial. J Psychiatr Res. 2018 Feb;97:77-83. doi: 10.1016/j.jpsychires.2017.12.002. Epub 2017 Dec 5.

  PMID: 29220825 BACKGROUND

• Carmenate L, Moncada FE, Borjas WE. Manual de medidas antropométricas. 1ª ed. Costa Rica: SALTRA, 2014.

  BACKGROUND

• Sevillano-Jimenez A, Romero-Saldana M, Garcia-Mellado JA, Carrascal-Laso L, Garcia-Rodriguez M, Molina-Luque R, Molina-Recio G. Impact of high prebiotic and probiotic dietary education in the SARS-CoV-2 era: improved cardio-metabolic profile in schizophrenia spectrum disorders. BMC Psychiatry. 2022 Dec 12;22(1):781. doi: 10.1186/s12888-022-04426-9.

  PMID: 36510155 DERIVED

• Sevillano-Jimenez A, Molina-Recio G, Garcia-Mellado JA, Garcia-Rodriguez M, Molina-Luque R, Romero-Saldana M. Efficacy of nutrition education for the increase of symbiotic intake on nutritional and metabolic status in schizophrenic spectrum disorders: A two-arm protocol. Front Nutr. 2022 Aug 10;9:912783. doi: 10.3389/fnut.2022.912783. eCollection 2022.

  PMID: 36034912 DERIVED

Related Links

• Junta de Andalucía. Instrumento de evaluación nº 8: Detección e intervención temprana en las psicosis. Escala para el síndrome positivo y negativo de la esquizofrenia (PANSS). Servicio Andaluz de Salud

MeSH Terms

Conditions

Schizophrenia; Feeding Behavior; Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse, Psychiatric-Mental Health Nurse Practitioner, Master Of Science, Doctoral Student

Model Details: Two-arm, double-blind, randomized clinical trial in balanced blocks of six months of intervention will be developed in a group of 50 individuals (25 for the intervention group -IG-,25 for the control group -CG-). The GC will receive conventional dietary advice on an individual basis. In the IG, an individual diet-nutrition education program with high prebiotic and probiotic content will be established. Data on psychopathological status (PANSS and PSP scales), and blood tests (haemogram, lipid profile, etc.),at the beginning, after three and six months. The estimate of intestinal microbiota and the usual nutritional pattern will be assessed at baseline and at six months, using a stool test and a validated food frequency questionnaire, respectively. To assess the degree of adherence, IG participants will fill in a specific weekly record of the main dishes/foods consumed. Anthropometric parameters will be analysed monthly (BMI, blood pressure, heart rate, abdominal perimeter).

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: April 28, 2020
• Study Start: June 25, 2020
• Primary Completion: October 19, 2021
• Study Completion: December 26, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ES (1)