Evaluation of the Effect of the Consumption of a Hypercaloric/Hyperproteic Formula in the Coverage of Nutritional Requirements in Patients With Chewing/Swallowing Problems That Require a Shredded Diet.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of nutritional changes with regard to the nutritional requirements recommended
研究概览
简要总结
Effect of a nutritional formula on the nutritional requirements in patients with chewing/swallowing problems during one month
详细描述
30 patients will receive nutritional education and guidelines for the consumption of a completed shreded diet including 2 packets of 90 grams every day (One salted packet for lunch/dinner and one sweet packet for breakfast/afternoon snack) and recommendations for physical activity for one month.
30 patients will receive nutritional education, guidelines for the consumption of a completed shreded diet and recommendations for physical activity during one month.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 18 years old.
- •Individuals with chewing/swallowing disorder.
- •Individuals well nourished or at malnutrition risk.
- •Adequate cultural level and understanding of the clinical trial.
- •Signed informed consent.
排除标准
- •Individuals with body mass index ≥40 kg/m
- •Individuals with acute, severe or chronic disease without control.
- •Individuals with major surgeries during the last month.
- •Individuals with gastrointestinal surgery the last three months.
- •Individuals with moderate/severe cognitive impairment.
- •Individuals with severe malnutrition.
- •Individuals with amyotrophic lateral sclerosis.
- •Individuals who consume nutritional oral supplements seven days prior to the start of the study.
- •Enteral or parenteral nutrition.
结局指标
主要结局
Percentage of nutritional changes with regard to the nutritional requirements recommended
时间窗: Up to one month
Change percentage = (energy consumption at the end of the intervention period - energy consumption at the beginning of the intervention period) / energy consumption at the beginning of the intervention period \* 100
次要结局
- 24h Dietary Recall Questionnaire(Up to one month)
- Adverse Effects(Up to one month)
- Tolerance and adverse effects(Up to one month)
- Functionality Variables(Up to one month)
- International Physical Activity Questionnaire(Up to one month)
- Sensory perception(Up to one month)
- Change from Baseline Anthropometric Parameters(Up to one month)