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Efficacy of Dietary Modulation With High Prebiotic and Probiotic Content on Nutritional and Metabolic Status in Schizophrenia Spectrum Disorders
Sponsor study identifier
interventional
44
1 country
1
Study Start
June 25, 2020
Actual (reported)Primary Completion
October 19, 2021
Actual (reported)Study Completion
December 26, 2023
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 26, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 18, 2020
Actual (reported)April 28, 2020
Actual (reported)June 25, 2020
Actual (reported)October 19, 2021
Actual (reported)December 26, 2023
Actual (reported)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
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).
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).
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.
Universidad de Córdoba.
Córdoba, 14071, Spain
Balanza Martinez V. Nutritional supplements in psychotic disorders. Actas Esp Psiquiatr. 2017 Sep;45(Supplement):16-25. Epub 2017 Sep 1.
American Psychiatric Association. Manual diagnóstico y estadístico de los trastornos mentales: DSM-5. Madrid: Editorial Médica Panamericana;2014.
Gómez AE. Nutrición y enfermedad mental. Esquizofrenia y ácidos grasos omega 3. Farmacia Profesional. 2007;21(3):60-63
44 participants (actual enrollment reported by the registry).
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
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.
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
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.
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
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.
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.
Rodríguez A, Solano M. Nutrición y salud mental: revisión bibliográfica. Rev Post Psiquiat UNAH. 2008;1(3):1-5.
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.
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.
Mariño A, Núñez M, Barreto J. Microbiota, probióticos, prebióticos y simbióticos. Pediatr Integral. 2015; 19(5):337-354.
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.
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.
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.
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.
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.
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.
Galletero JM. Nutrición y enfermedad mental. Marcadores bioquímicos en el trastorno bipolar. Zainak. 2011;34:323-334
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
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.
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
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.
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.
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.
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.
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.
Cortés B. Síndrome metabólico y antipsicóticos de segunda generación. Rev Asoc Esp Neuropsiq. 2011;31(110):303-320. DOI: 10.4321/S0211-57352011000200009
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.
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.
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.
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
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
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
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
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
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.
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
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.
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.
Carmenate L, Moncada FE, Borjas WE. Manual de medidas antropométricas. 1ª ed. Costa Rica: SALTRA, 2014.
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.
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.
First Submitted
April 18, 2020
First Posted
April 28, 2020
Study Start
June 25, 2020
Actual (reported)Primary Completion
October 19, 2021
Actual (reported)Study Completion
December 26, 2023
Actual (reported)Last Updated
May 9, 2024
Record last verified: 2024-05
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