Clinical trial NCT01286389: Caloric Restriction in Obese Patients With Mild Cognitive Impairment: Effects on Adiposity, Comorbidity and Cognition
Official title: Caloric Restriction in Obese Patients With Mild Cognitive Impairment: Effects on Adiposity, Comorbidity and Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Obesity
Keywords: Mild cognitive impairment
Dementia
Obesity
Overweight
diet
caloric restriction
body composition
weight loss
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-01-31
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neuropsychological test performance
timeFrame: baseline and 12 months
measure: Diagnosis of dementia
timeFrame: 12 months
measure: Weight loss
timeFrame: 12 months
Secondary outcomes:
measure: plasma biomarkers
timeFrame: 0 and 12 months
measure: Genotyping apolipoprotein E
timeFrame: baseline
measure: Charlson comorbidity index
timeFrame: 0 and 12 moths
measure: International physical activity questionnaire- short version (IPAQ)
timeFrame: 0 and 12 moths
measure: Evaluation of Food Consumption
timeFrame: 0 and 12 moths
measure: SPPB- Short physical performance battery
timeFrame: 0 and 12 moths
measure: Blood pressure
timeFrame: 0 and 12 moths
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas - Faculdade de Medicina da USP
Study officials:
affiliation: Sao Paulo University
name: Alfredo Hapern, professor
role: STUDY_DIRECTOR
affiliation: pos graduation student of Sao Paulo University
name: Nídia Horie
role: PRINCIPAL_INVESTIGATOR
affiliation: Sao Paulo University
name: Cintia Cercato, professor
role: STUDY_CHAIR
References: