NCT01303289已完成不适用
Clinical Evaluation of a Normoproteic Diet With Ultra High Temperature Treatment
Vegenat, S.A.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Nutritional status evaluation
研究概览
简要总结
The main objective of this trial is the clinical evaluation of a normoproteic diet, when this diet is used for total enteral nutrition in geriatric people.
For 3 months,all the participants in the study will receive only tube feeding: The experimental group will receive the commercial preparation to evaluate (T-Diet Plus ®, Vegenat SA) and the control group will receive a standard diet (Jevity ®, Abbott Laboratories).
详细描述
The project includes:
- Product tolerance study: gastrointestinal and metabolic complications related to the product administration.
- The monitoring of the intervention, and clinical and nutritional evaluation of the participants, including anthropometry, quality of life related to the health and clinical and nutritional status analytical evaluation (hematology and biochemistry).
- The determination of the major biochemical variables related to the lipid profile and assessment of the antioxidant defense system, and also certain markers of metabolic syndrome and associated cardiovascular risk.
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
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 65 years old, of both sex, receiving total enteral nutrition by tube.
- •Admitted to medically supervised institutions (homes, health centers).
- •Requirement for total enteral nutrition standard, at least 3 months.
- •Acceptance volunteer to participate in the study by signing the written informed consent (approved by the Ethics Committee of University Hospital Virgen de las Nieves).
排除标准
- •Patients who receive drugs with lipid composition.
- •Unstable clinical situation.
- •Patients with terminal illness.
- •Refusal or physical or mental inability to cooperate in the study.
- •Participating in another study.
- •Other causes: social causes, humanitarian, non-cooperation, etc..
结局指标
主要结局
Nutritional status evaluation
时间窗: 6 months
Clinical evaluation of a comercial product: T-Diet Plus (normoproteic and specific diet), when is used for total enteral nutrition in geriatric people.
次要结局
- Specific parameters measure(6 months)
研究者
研究点 (2)
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