Caloric Restriction in Obese Patients With Mild Cognitive Impairment: Effects on Adiposity, Comorbidity and Cognition
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Neuropsychological test performance
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
No
Alfredo Hapern, professor
Study Director
Sao Paulo University
Brazil: National Committee of Ethics in Research
0706/10 CAPPesq
NCT01286389
January 2011
June 2013
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