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Caloric Restriction in Obese Patients With Mild Cognitive Impairment: Effects on Adiposity, Comorbidity and Cognition

4 de noviembre de 2014 actualizado por: Nídia Celeste Horie, University of Sao Paulo General Hospital
Obesity has been associated with cognitive impairments, lower blood flow, metabolic activity and brain volume. Obesity in adulthood is a risk factor for Alzheimer's disease in the elderly. The mild cognitive impairment (MCI) is a condition that may precede dementia. We hypothesized that promotion of weight loss in obese people with MCI, through caloric restriction could lead to improvement in cognitive performance or reduction in the rate of decline and decreased risk of dementia. A sample of 80 patients aged ≥ 60 years, obese, with MCI, will be randomized to two groups that will be followed for 12 months. The control group will receive conventional medical care. The intervention group will receive nutritional counseling individually and in groups, aiming to promote weight loss through caloric restriction, and medical monitoring. Before and after intervention patients will be evaluated for anthropometry, body composition, physical performance, control of comorbidities, laboratory tests (glucose, insulin, lipid profile, leptin, adiponectin, interleukin 6, tumor necrosis factor alpha, CRP), Genotyping apolipoprotein E, neuropsychological battery, questionnaires about activities of daily living, physical activity and diet.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Objectives: To evaluate the cognitive performance of obese patients with MCI and the effect of weight loss induced by caloric restriction on cognition, conversion to dementia, to assess weight loss, changes in inflammatory and metabolic parameters, change in physical capacity, performance in neuropsychological tests and correlate with effects of the intervention. Methods: The patients will be randomized to two groups that will be followed for 12 months. The control group will receive conventional medical care. The intervention group will receive nutritional counseling individually and in groups, aiming to promote weight loss (10% of body weight) through caloric restriction, and medical monitoring. Everyone will be advised to physical activity. Before and after 12 months patients will be evaluated for anthropometry, body composition, physical performance, control of comorbidities, laboratory tests (glucose, insulin, lipid profile, leptin, adiponectin, interleukin 6, tumor necrosis factor alpha, CRP), Genotyping apolipoprotein E, neuropsychological battery, questionnaires about activities of daily living, physical activity and diet.

Tipo de estudio

Intervencionista

Inscripción (Actual)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Brasil
      • Sao Paulo, Brasil, 05403010
        • Hospital das Clínicas - Faculdade de Medicina da USP

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

60 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • body mass index (BMI) ≥ 30 kg/m2
  • independent for most of the instrumental activities of daily life;
  • literate;
  • able to walk,
  • diagnosis of mild cognitive impairment

Exclusion Criteria:

  • weight loss greater than 3 kg over the past two months,
  • presence of uncontrolled disease that potentially interfere with metabolism and weight gain or whose treatment would influence the cognitive performance, such as major depression, bulimia, hypothyroidism, Cushing's disease, heart failure, neoplasia in the last 3 years, alcoholism, infectious diseases and auto-immune activity;
  • use of anti-obesity drugs, benzodiazepines, neuroleptics or estrogen replacement therapy in the past 2 months;
  • previous bariatric surgery,
  • severe sensory deficit

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Conventional medical care
Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet)
Otro: medical care
Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet)
Experimental: caloric restriction +medical care
Nutritional counseling individually and in groups, aiming to promote weight loss (10% of body weight) through caloric restriction, +Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise)
Otro: medical care
Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet)
Conductual: caloric restriction
Nutritional guidance: through at least 2 individual assistance and group sessions, lasting 1 hour, weekly for 4 months, and biweekly for 2 months and monthly thereafter (26-28 meetings/1year).The diet plan will recommend a deficit from 500 to 750 kcal/day in order to promote loss of about 0.5kg/week, containing 1g/kg of protein per day (minimum 1200kcal/day), high in fiber, vegetables and whole foods. The goal of weight loss will be 10% of initial weight. Group activities consist of lectures on nutrition education, food composition and its importance to health, food preparation techniques, self-monitoring weight, eating behavior and count calories.
Otros nombres:
  • dieta

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Neuropsychological test performance
Periodo de tiempo: baseline and 12 months
Montreal Cognitive Assessment (MoCA), Mini Mental State Examination (MMSE), Subjective Memory Complaints scale and CAMcog from CAMDEX (The Cambridge Examination for Mental Disorders of the Elderly, The Rivermead Behavioural Memory, The Wisconsin Card Sorting Task, trail making test part A and B, The Rey auditory-verbal learning test, semantic and phonologic verbal fluency test, digits (WAIS-III), vocabulary (WAIS - III), matrix (WAIS - III)
baseline and 12 months
Diagnosis of dementia
Periodo de tiempo: 12 months
The diagnosis of dementia will be given from the DSM IV TR: The diagnosis of Alzheimer's disease will be defined according to DSM IV.
12 months
Weight loss
Periodo de tiempo: 12 months
anthropometry (weight, height, BMI, waist circumference, hip circumference), body composition by bioimpedance
12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
plasma biomarkers
Periodo de tiempo: 0 and 12 months
glucose, insulin, lipid profile, leptin, adiponectin, interleukin 6, tumor necrosis factor alpha, CRP
0 and 12 months
Genotyping apolipoprotein E
Periodo de tiempo: baseline
The genotype is a covariate to assess response to treatment
baseline
Charlson comorbidity index
Periodo de tiempo: 0 and 12 moths
0 and 12 moths
International physical activity questionnaire- short version (IPAQ)
Periodo de tiempo: 0 and 12 moths
0 and 12 moths
Evaluation of Food Consumption
Periodo de tiempo: 0 and 12 moths
0 and 12 moths
SPPB- Short physical performance battery
Periodo de tiempo: 0 and 12 moths
0 and 12 moths
Blood pressure
Periodo de tiempo: 0 and 12 moths
0 and 12 moths

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Sao Paulo General Hospital

Colaboradores

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigadores

  • Director de estudio: Alfredo Hapern, professor, Sao Paulo University
  • Investigador principal: Nídia Horie, pos graduation student of Sao Paulo University
  • Silla de estudio: Cintia Cercato, professor, Sao Paulo University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2011

Finalización primaria (Actual)

1 de mayo de 2013

Finalización del estudio (Actual)

1 de octubre de 2014

Fechas de registro del estudio

Enviado por primera vez

27 de enero de 2011

Primero enviado que cumplió con los criterios de control de calidad

27 de enero de 2011

Publicado por primera vez (Estimar)

31 de enero de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

5 de noviembre de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

4 de noviembre de 2014

Última verificación

1 de noviembre de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 0706/10 CAPPesq

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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