Metabolic Syndrome Clinical Trial
Official title:
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
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