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

Purpose

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.

Condition	Intervention
Mild Cognitive Impairment Obesity	Behavioral: caloric restriction

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Caloric Restriction in Obese Patients With Mild Cognitive Impairment: Effects on Adiposity, Comorbidity and Cognition

Resource links provided by NLM:

MedlinePlus related topics: Dementia Mild Cognitive Impairment Obesity Weight Control

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:

Neuropsychological test performance [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
anthropometry (weight, height, BMI, waist circumference, hip circumference), body composition by bioimpedance

Secondary Outcome Measures:

plasma biomarkers [ Time Frame: 0 and 12 months ] [ Designated as safety issue: No ]
glucose, insulin, lipid profile, leptin, adiponectin, interleukin 6, tumor necrosis factor alpha, CRP
Genotyping apolipoprotein E [ Time Frame: baseline ] [ Designated as safety issue: No ]
The genotype is a covariate to assess response to treatment
Charlson comorbidity index [ Time Frame: 0 and 12 moths ] [ Designated as safety issue: No ]
International physical activity questionnaire- short version (IPAQ) [ Time Frame: 0 and 12 moths ] [ Designated as safety issue: No ]
Evaluation of Food Consumption [ Time Frame: 0 and 12 moths ] [ Designated as safety issue: No ]
Exercise test [ Time Frame: 0 and 12 moths ] [ Designated as safety issue: Yes ]
Modified Bruce protocol
Blood pressure [ Time Frame: 0 and 12 moths ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	January 2011
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Lifestyle counseling, medical monitoring Geriatric consultations at least 6 times in 12 months	Behavioral: 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.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, 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. Outpatient medical care for a period of 12 months, with at least six individual consultations, directed towards control of comorbidities and weight loss. Other Name: diet
Experimental: caloric restriction Nutritional counseling individually and in groups, aiming to promote weight loss (10% of body weight) through caloric restriction, and medical monitoring	Behavioral: 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.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, 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. Outpatient medical care for a period of 12 months, with at least six individual consultations, directed towards control of comorbidities and weight loss. Other Name: diet

Arms

Assigned Interventions

Placebo Comparator: Lifestyle counseling, medical monitoring

Geriatric consultations at least 6 times in 12 months

Behavioral: 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.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, 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.

Outpatient medical care for a period of 12 months, with at least six individual consultations, directed towards control of comorbidities and weight loss.

Other Name: diet

Experimental: caloric restriction

Nutritional counseling individually and in groups, aiming to promote weight loss (10% of body weight) through caloric restriction, and medical monitoring

Behavioral: 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.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, 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.

Outpatient medical care for a period of 12 months, with at least six individual consultations, directed towards control of comorbidities and weight loss.

Other Name: 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

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 activity;
use of anti-obesity drugs, benzodiazepines, neuroleptics or estrogen replacement therapy in the past 2 months;
previous bariatric surgery,
severe sensory deficit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286389

Contacts

Contact: Nídia Horie, MD

5511-23658517

nidia.horie@usp.br

Locations

Brazil
Hospital das Clínicas - Faculdade de Medicina da USP	Recruiting
Sao Paulo, Brazil, 05403010
Contact: Nidia Horie nidia.horie@usp.br

Sponsors and Collaborators

University of Sao Paulo General Hospital

Investigators

Study Director:	Alfredo Hapern, professor	Sao Paulo University
Principal Investigator:	Nídia Horie	pos graduation student of Sao Paulo University
Study Chair:	Cintia Cercato, professor	Sao Paulo University

More Information

No publications provided

Responsible Party:	Prof Dr Alfredo Halpern, University of Sao Paulo General Hospital - Endocrinology
ClinicalTrials.gov Identifier:	NCT01286389 History of Changes
Other Study ID Numbers:	0706/10 CAPPesq
Study First Received:	January 27, 2011
Last Updated:	April 13, 2011
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:

Mild cognitive impairment
Dementia
Obesity
Overweight

diet
caloric restriction
body composition
weight loss

Additional relevant MeSH terms:

Obesity
Cognition Disorders
Overnutrition
Nutrition Disorders
Overweight

Body Weight
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013