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

60 Years
Open (Enrolling)
Mild Cognitive Impairment, Obesity

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Trial Information

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.

Inclusion Criteria:

- body mass index (BMI) ≥ 27 kg/m2 and a waist circumference greater than or equal to
102 cm for men and 88 cm for women; or BMI ≥ 30kg/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

- use of anti-obesity drugs, benzodiazepines, neuroleptics or estrogen replacement
therapy in the past 2 months;

- previous bariatric surgery,

- severe sensory deficit

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Neuropsychological test performance

Outcome Description:

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)

Outcome Time Frame:

baseline and 12 months

Safety Issue:


Principal Investigator

Alfredo Hapern, professor

Investigator Role:

Study Director

Investigator Affiliation:

Sao Paulo University


Brazil: National Committee of Ethics in Research

Study ID:

0706/10 CAPPesq



Start Date:

January 2011

Completion Date:

June 2013

Related Keywords:

  • Mild Cognitive Impairment
  • Obesity
  • Mild cognitive impairment
  • Dementia
  • Obesity
  • Overweight
  • diet
  • caloric restriction
  • body composition
  • weight loss
  • Obesity
  • Cognition Disorders