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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Sao Paulo General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01286389
First received: January 27, 2011
Last updated: April 13, 2011
Last verified: January 2011
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 08, 2014