Caloric Restriction in Obese Patients With Mild Cognitive Impairment: Effects on Adiposity, Comorbidity and Cognition
4 november 2014 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
80
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Sao Paulo, Brazilië, 05403010
- Hospital das Clínicas - Faculdade de Medicina da USP
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
60 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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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Experimenteel: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Neuropsychological test performance
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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plasma biomarkers
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 0 and 12 moths
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0 and 12 moths
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International physical activity questionnaire- short version (IPAQ)
Tijdsspanne: 0 and 12 moths
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0 and 12 moths
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Evaluation of Food Consumption
Tijdsspanne: 0 and 12 moths
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0 and 12 moths
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SPPB- Short physical performance battery
Tijdsspanne: 0 and 12 moths
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0 and 12 moths
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Blood pressure
Tijdsspanne: 0 and 12 moths
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0 and 12 moths
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie directeur: Alfredo Hapern, professor, Sao Paulo University
- Hoofdonderzoeker: Nídia Horie, pos graduation student of Sao Paulo University
- Studie stoel: Cintia Cercato, professor, Sao Paulo University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2011
Primaire voltooiing (Werkelijk)
1 mei 2013
Studie voltooiing (Werkelijk)
1 oktober 2014
Studieregistratiedata
Eerst ingediend
27 januari 2011
Eerst ingediend dat voldeed aan de QC-criteria
27 januari 2011
Eerst geplaatst (Schatting)
31 januari 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
5 november 2014
Laatste update ingediend die voldeed aan QC-criteria
4 november 2014
Laatst geverifieerd
1 november 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 0706/10 CAPPesq
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