Clinical Evaluation of an Specific Diet for People With Dementia Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 184
- 试验地点
- 6
- 主要终点
- Nutritional and cognitive status in elderly people
研究概览
简要总结
The most common symptoms associated to senile dementia disease are confusion about schedules, hyperactivity... In this sense, these patients have frequently poor nutrition, resulting in malnutrition problems or malnutrition high risk.
详细描述
The purpose of this study is to assess if the daily intake of a specific nutritional supplement versus a non specific supplement one is related to malnutrition or malnutrition risk reduction and contributes to an improvement in cognitive and functional parameters in patients with senile dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 70 years with neurologist or geriatrician dementia diagnosis (Alzheimer's disease, Parkinson's or mixed), with mild or moderate cognitive impairment degree (Between 24 and 14 MMSE).
- •Patients with or at malnutrition risk (Mini Nutritional Assessment screening positive)
排除标准
- •Patients with decompensated kidney failure, creatine and/or bilirubin greater than 2, uric acid higher than 8 mg/dl, and glomerular filtration under 60 ml/minute.
- •Patients with Diabetes mellitus poorly controlled (Glycemia > 200 mg/dl)
- •Patients with decompensated hypertension.
- •Patients with pharmacological treatment or consuming supplements containing specific supplementation of experimental product (omega 3 and/or vitamins supplements).
- •Post-stroke vascular dementias.
- •Do not achieve any inclusion criteria.
结局指标
主要结局
Nutritional and cognitive status in elderly people
时间窗: 1 year
The evaluation include: Nutritional evaluation, Improvement of Anthropometric and Biochemical parameters evaluation in relation to patient malnutrition, Patient's cognitive status evaluation (Folstein's MMSE and GDS scale), Functional and psychopathological aspects evaluation (blessed Scale), Global Impresion of Change Evaluation(CIBIC plus Scale), Quality of life evaluation (Short Form 36 questionaire), Memory Evaluation (Rey Auditory Learning Test), Appearance of gastrointestinal events evaluation, Diet and Intake acceptance evaluation.
次要结局
- Biochemical parameters measure(8 months)