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

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

Interventions

OTHER

medical care

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

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 (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.

Sponsors & Collaborators

• Fundação de Amparo à Pesquisa do Estado de São Paulo

  collaborator OTHER_GOV

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Alfredo Hapern, professor · Sao Paulo University

• Nídia Horie · pos graduation student of Sao Paulo University

• Cintia Cercato, professor · Sao Paulo University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2013-05-31

Completion

2014-10-31

Countries

• Brazil

Study Locations