Clinical Evaluation of a Specific Enteral Diet for Diabetics

Clinical Evaluation of a Specific Enteral Diet for Diabetics.A Randomised Cross-Over Study

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).

This new complete diet has been carefully formulated, and incorporates functional ingredients based on:

1. A good gastrointestinal and metabolic tolerance of the product.
2. Beneficial outcomes in the nutritional status.
3. 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).

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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