Safety and Acceptance of GourMed© Prepackaged Nutritional Products in the Elderly Dysphagic Patient: MODiet Project
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- safety of GourMed© meal
研究概览
简要总结
The aim of the MoDiet study is to evaluate the usefulness of the GourMed© prepackaged diet in guaranteeing a safe, compliant and effective diet satisfying the nutritional needs of the elderly dysphagic patient.
详细描述
The objective of the MoDiet study is to evaluate the usefulness of the GourMed© (MedicAir Food srl, Milano, Italy) prepackaged diet in guaranteeing a safe, compliant and effective diet satisfying the nutritional needs of the elderly dysphagic patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •age 65 years and over
- •Gugging Swallowing Screen ranging 10-20;
排除标准
- •known or suspected intolerance to any ingredient
- •taking other prepackaged products for dysphagia
- •creatinine ≥1,5 mg/dl
结局指标
主要结局
safety of GourMed© meal
时间窗: during each GourMed© meal (up to day 7)
The safety of GourMed© meal is monitoring by the registration of the following events: * Appearance of coughing and/or changes in the tone of voice immediately after or within 1-2 minutes of swallowing a bite; * Spill of food from the nose; * Prolonged management of the bolus in the oral cavity * Appearance of red or cyanotic color on the face * Occurrence of allergic skin reactions * Appearance of breathing difficulties * Onset of fever * Appearance of nausea, vomiting or diarrhea.
次要结局
- evaluate the amount of GourMet© meal consumed(after each GourMed© meal (up to day 7))