Clinical Evaluation of a Specific Enteral Diet for Diabetics

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: 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).

T-Diet plus Diabet NP, Diabetic, Enteral Nutrition, Glycaemic response, Metabolic Syndrome, Insulin resistance, Lipidic profile

The group 1 will receive the experimental product T-Diet plus Diabet NP for the first month followed by a reference diet corresponding to a current marketed product (Glucerna SR, Abbott) for the second month, then the patients will receive a control product non specific for diabetic patients (T-Diet plus Standard)for the third month, and finally a specific diet for diabetic patients (Novasource, Nestlé Healthcare Nutrition)for the fourth month.

The group 2 will receive a reference diet corresponding to a current marketed product (Glucerna SR, Abbott)for the first month, followed by the experimental product T-Diet plus Diabet NP for the second month, then the patients will receive a specific diet for diabetic patients (Novasource, Nestlé Healthcare Nutrition)for the third month, and finally a control product non specific for diabetic patients (T-Diet plus Standard)for the fourth month

T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition.

T-Diet plus Diabet NP is a complete balanced oral nutrition supplement, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.

GLUCERNA 1.0 CAL is a reduced-carbohydrate, modified-fat, fiber-containing formula clinically shown to blunt blood-glucose response in patients with abnormal glucose tolerance.

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

Confirmation of gastrointestinal tolerance of the product To assess changes in glycaemic response and lipidic profile in theses patients in relation with the diet, including parameters characteristic of metabolic syndrome, insulin resistace and hunger-satiety mechanism. To analyse changes of incretins and gastrointestinal peptides levels. To compare inflammatory and endothelial damage markers related with cardiovascular morbidity. Genotyping and gene expression analysis of genes related with diabetes and insulin resistance

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