Clinical Evaluation of a Specific Enteral Diet for Diabetics.A Randomised Cross-Over Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Nutritional status and Glycaemia
研究概览
简要总结
The hypothesis of the proposed trials is that the regular intake of a specific diet designed for enteral nutrition of type 2 diabetic patients results into a better nutritional status. Thus, the aim of the study is to scientifically evaluate the healthy effects of the administration of an enteral complete diet for diabetic patients (T-Diet plus Diabet).
详细描述
This new complete diet has been carefully formulated, and incorporates functional ingredients based on:
- A good gastrointestinal and metabolic tolerance of the product.
- Beneficial outcomes in the nutritional status.
- A good control of the glycaemic response and the lipidic profile, allowing an improvement of metabolic syndrome and insulin resistance indicators and hunger-satiety regulation.
The experimental enteral product is a complete diet that includes, as carbohydrates, high-molecular maltodextrin, resistant maltodextrin, fructooligosaccharides and cellulose, and does not contain added fructose. Indeed, this product contains eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic Subjects older than 55 years.
- •Male or female
- •Requirement of total enteral nutrition (TEN) during at least 3 months.
- •Under medical supervision.
- •Voluntary informed consent for participation.
排除标准
- •Unstable clinical situation
- •Fatal illness
- •Patients treated with lipidic drugs
- •Refusal to participate in the study or being enrolled in other clinical trials.
- •Social or humanitarian reason
结局指标
主要结局
Nutritional status and Glycaemia
时间窗: 9 months
* Evaluation of the nutritional status of diabetic patients fed the T-Diet Plus Diabet NP in comparison with the reference and the control diet. * Evaluation of glycaemia and glycosylated hemoglobin
次要结局
- Biochemicals parameters measure(9 months)