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

NCT01286389 | Completed

• 1 other identifier: 0706/10 CAPPesq
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Obesity

Keywords

Mild cognitive impairment; Dementia; Obesity; Overweight; diet; caloric restriction; body composition; weight loss

Outcome Measures

Primary Outcomes (3)

• 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)

  baseline and 12 months

• 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.

  12 months

• Weight loss

  anthropometry (weight, height, BMI, waist circumference, hip circumference), body composition by bioimpedance

  12 months

Secondary Outcomes (7)

• plasma biomarkers

  0 and 12 months

• Genotyping apolipoprotein E

  baseline

• Charlson comorbidity index

  0 and 12 moths

• International physical activity questionnaire- short version (IPAQ)

  0 and 12 moths

• Evaluation of Food Consumption

  0 and 12 moths

Study Arms (2)

Conventional medical care

ACTIVE COMPARATOR

Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet)

Other: medical care

caloric restriction +medical care

EXPERIMENTAL

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)

Other: medical care; Behavioral: caloric restriction

Interventions

medical care OTHER

Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet)

Conventional medical care; caloric restriction +medical care

caloric restriction BEHAVIORAL

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.

Also known as: diet

caloric restriction +medical care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Hospital das Clínicas - Faculdade de Medicina da USP

São Paulo, São Paulo, 05403010, Brazil

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Obesity; Dementia; Overweight; Weight Loss

Interventions

Caloric Restriction; Diet

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Body Weight Changes

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Alfredo Hapern, professor

  Sao Paulo University

  STUDY DIRECTOR

• Nídia Horie

  pos graduation student of Sao Paulo University

  PRINCIPAL INVESTIGATOR

• Cintia Cercato, professor

  Sao Paulo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: January 31, 2011
• Study Start: January 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: October 1, 2014
• Last Updated: November 5, 2014

Record last verified: 2014-11

Locations

BR (1)