Caloric Restriction in Obese Patients With Mild Cognitive Impairment: Effects on Adiposity, Comorbidity and Cognition
Primary Purpose
Mild Cognitive Impairment, Obesity
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
medical care
caloric restriction
Sponsored by

About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild cognitive impairment, Dementia, Obesity, Overweight, diet, caloric restriction, body composition, weight loss
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
Sites / Locations
- Hospital das Clínicas - Faculdade de Medicina da USP
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional medical care
caloric restriction +medical care
Arm Description
Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet)
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)
Outcomes
Primary Outcome Measures
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)
Diagnosis of dementia
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.
Weight loss
anthropometry (weight, height, BMI, waist circumference, hip circumference), body composition by bioimpedance
Secondary Outcome Measures
plasma biomarkers
glucose, insulin, lipid profile, leptin, adiponectin, interleukin 6, tumor necrosis factor alpha, CRP
Genotyping apolipoprotein E
The genotype is a covariate to assess response to treatment
Charlson comorbidity index
International physical activity questionnaire- short version (IPAQ)
Evaluation of Food Consumption
SPPB- Short physical performance battery
Blood pressure
Full Information
NCT ID
NCT01286389
First Posted
January 27, 2011
Last Updated
November 4, 2014
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01286389
Brief Title
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
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Obesity
Keywords
Mild cognitive impairment, Dementia, Obesity, Overweight, diet, caloric restriction, body composition, weight loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional medical care
Arm Type
Active Comparator
Arm Description
Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet)
Arm Title
caloric restriction +medical care
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
medical care
Intervention Description
Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet)
Intervention Type
Behavioral
Intervention Name(s)
caloric restriction
Other Intervention Name(s)
diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neuropsychological test performance
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)
Time Frame
baseline and 12 months
Title
Diagnosis of dementia
Description
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.
Time Frame
12 months
Title
Weight loss
Description
anthropometry (weight, height, BMI, waist circumference, hip circumference), body composition by bioimpedance
Time Frame
12 months
Secondary Outcome Measure Information:
Title
plasma biomarkers
Description
glucose, insulin, lipid profile, leptin, adiponectin, interleukin 6, tumor necrosis factor alpha, CRP
Time Frame
0 and 12 months
Title
Genotyping apolipoprotein E
Description
The genotype is a covariate to assess response to treatment
Time Frame
baseline
Title
Charlson comorbidity index
Time Frame
0 and 12 moths
Title
International physical activity questionnaire- short version (IPAQ)
Time Frame
0 and 12 moths
Title
Evaluation of Food Consumption
Time Frame
0 and 12 moths
Title
SPPB- Short physical performance battery
Time Frame
0 and 12 moths
Title
Blood pressure
Time Frame
0 and 12 moths
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfredo Hapern, professor
Organizational Affiliation
Sao Paulo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nídia Horie
Organizational Affiliation
pos graduation student of Sao Paulo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cintia Cercato, professor
Organizational Affiliation
Sao Paulo University
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital das Clínicas - Faculdade de Medicina da USP
City
Sao Paulo
ZIP/Postal Code
05403010
Country
Brazil
12. IPD Sharing Statement
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Caloric Restriction in Obese Patients With Mild Cognitive Impairment: Effects on Adiposity, Comorbidity and Cognition
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