- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01286389
Caloric Restriction in Obese Patients With Mild Cognitive Impairment: Effects on Adiposity, Comorbidity and Cognition
4 november 2014 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Sao Paulo, Brasilien, 05403010
- Hospital das Clínicas - Faculdade de Medicina da USP
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
60 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Conventional medical care
Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet)
|
Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet)
|
Experimentell: 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)
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Neuropsychological test performance
Tidsram: baseline and 12 months
|
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
Tidsram: 12 months
|
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
Tidsram: 12 months
|
anthropometry (weight, height, BMI, waist circumference, hip circumference), body composition by bioimpedance
|
12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
plasma biomarkers
Tidsram: 0 and 12 months
|
glucose, insulin, lipid profile, leptin, adiponectin, interleukin 6, tumor necrosis factor alpha, CRP
|
0 and 12 months
|
Genotyping apolipoprotein E
Tidsram: baseline
|
The genotype is a covariate to assess response to treatment
|
baseline
|
Charlson comorbidity index
Tidsram: 0 and 12 moths
|
0 and 12 moths
|
|
International physical activity questionnaire- short version (IPAQ)
Tidsram: 0 and 12 moths
|
0 and 12 moths
|
|
Evaluation of Food Consumption
Tidsram: 0 and 12 moths
|
0 and 12 moths
|
|
SPPB- Short physical performance battery
Tidsram: 0 and 12 moths
|
0 and 12 moths
|
|
Blood pressure
Tidsram: 0 and 12 moths
|
0 and 12 moths
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Studierektor: Alfredo Hapern, professor, Sao Paulo University
- Huvudutredare: Nídia Horie, pos graduation student of Sao Paulo University
- Studiestol: Cintia Cercato, professor, Sao Paulo University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2011
Primärt slutförande (Faktisk)
1 maj 2013
Avslutad studie (Faktisk)
1 oktober 2014
Studieregistreringsdatum
Först inskickad
27 januari 2011
Först inskickad som uppfyllde QC-kriterierna
27 januari 2011
Första postat (Uppskatta)
31 januari 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
5 november 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 november 2014
Senast verifierad
1 november 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 0706/10 CAPPesq
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Fetma
-
SanionaAvslutadHypothalamic Injury-induced Obesity (HIO)Danmark
Kliniska prövningar på medical care
-
Chunrui LiNanjing IASO Biotechnology Co., LtdRekryteringPlasmacellleukemi | Återfall/refraktärt multipelt myelomKina
-
Soterix MedicalGeorgetown University; National Institute of Neurological Disorders and... och andra samarbetspartnersAvslutadKronisk afasiFörenta staterna
-
Soterix MedicalNYU Langone HealthAvslutadBehandling Resistent depression | Unipolär depressionFörenta staterna
-
Baylor College of MedicineAktiv, inte rekryterandeNeuralrörsdefekterFörenta staterna
-
Cellular Biomedicine Group Ltd.The First Affiliated Hospital with Nanjing Medical UniversityAvslutadEn fas 1-studie som utvärderar säkerhet och effekt av C-CAR011-behandling hos DLBCL-ämnen (C-CAR011)Refraktärt diffust stort B-cellslymfomKina
-
University of WashingtonAvslutadHypertrofisk ärrbildning efter brännskadaFörenta staterna
-
Zhejiang UniversityCarbiogene Therapeutics Co. Ltd.Har inte rekryterat ännuKlinisk prövning av autologa GPC3 CAR-T-celler (CBG166) terapi för avancerad hepatocellulär karcinomAvancerat hepatocellulärt karcinomKina
-
Nexcella Inc.Har inte rekryterat ännuLätt kedja (AL) amyloidosFörenta staterna
-
Second Affiliated Hospital, School of Medicine,...RekryteringÅterfall och refraktärt B-cellslymfomKina
-
Second Affiliated Hospital, School of Medicine,...RekryteringB-cells non-Hodgkin lymfomKina