Caloric Restriction in Obese Patients With Mild Cognitive Impairment: Effects on Adiposity, Comorbidity and Cognition
4 novembre 2014 mis à jour par: Nídia Celeste Horie, University of Sao Paulo General Hospital
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
80
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Sao Paulo, Brésil, 05403010
- Hospital das Clínicas - Faculdade de Medicina da USP
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
60 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Conventional medical care
Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet)
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Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet)
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Expérimental: caloric restriction +medical care
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)
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Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet)
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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Neuropsychological test performance
Délai: baseline and 12 months
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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)
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baseline and 12 months
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Diagnosis of dementia
Délai: 12 months
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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.
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12 months
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Weight loss
Délai: 12 months
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anthropometry (weight, height, BMI, waist circumference, hip circumference), body composition by bioimpedance
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12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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plasma biomarkers
Délai: 0 and 12 months
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glucose, insulin, lipid profile, leptin, adiponectin, interleukin 6, tumor necrosis factor alpha, CRP
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0 and 12 months
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Genotyping apolipoprotein E
Délai: baseline
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The genotype is a covariate to assess response to treatment
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baseline
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Charlson comorbidity index
Délai: 0 and 12 moths
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0 and 12 moths
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International physical activity questionnaire- short version (IPAQ)
Délai: 0 and 12 moths
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0 and 12 moths
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Evaluation of Food Consumption
Délai: 0 and 12 moths
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0 and 12 moths
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SPPB- Short physical performance battery
Délai: 0 and 12 moths
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0 and 12 moths
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Blood pressure
Délai: 0 and 12 moths
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0 and 12 moths
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Alfredo Hapern, professor, Sao Paulo University
- Chercheur principal: Nídia Horie, pos graduation student of Sao Paulo University
- Chaise d'étude: Cintia Cercato, professor, Sao Paulo University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2011
Achèvement primaire (Réel)
1 mai 2013
Achèvement de l'étude (Réel)
1 octobre 2014
Dates d'inscription aux études
Première soumission
27 janvier 2011
Première soumission répondant aux critères de contrôle qualité
27 janvier 2011
Première publication (Estimation)
31 janvier 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
5 novembre 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 novembre 2014
Dernière vérification
1 novembre 2014
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 0706/10 CAPPesq
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