Caloric Restriction in Obese Patients With Mild Cognitive Impairment: Effects on Adiposity, Comorbidity and Cognition
2014年11月4日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
80
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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Sao Paulo、ブラジル、05403010
- Hospital das Clínicas - Faculdade de Medicina da USP
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
60年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Neuropsychological test performance
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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plasma biomarkers
時間枠：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
時間枠：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
時間枠：0 and 12 moths
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0 and 12 moths
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International physical activity questionnaire- short version (IPAQ)
時間枠：0 and 12 moths
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0 and 12 moths
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Evaluation of Food Consumption
時間枠：0 and 12 moths
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0 and 12 moths
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SPPB- Short physical performance battery
時間枠：0 and 12 moths
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0 and 12 moths
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Blood pressure
時間枠：0 and 12 moths
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0 and 12 moths
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Alfredo Hapern, professor、Sao Paulo University
- 主任研究者：Nídia Horie、pos graduation student of Sao Paulo University
- スタディチェア：Cintia Cercato, professor、Sao Paulo University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年1月1日
一次修了 (実際)
2013年5月1日
研究の完了 (実際)
2014年10月1日
試験登録日
最初に提出
2011年1月27日
QC基準を満たした最初の提出物
2011年1月27日
最初の投稿 (見積もり)
2011年1月31日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年11月5日
QC基準を満たした最後の更新が送信されました
2014年11月4日
最終確認日
2014年11月1日
詳しくは
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