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Clinical Trial Summary

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).


Clinical Trial Description

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). ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT01247714
Study type Interventional
Source Vegenat, S.A.
Contact
Status Active, not recruiting
Phase N/A
Start date September 2009
Completion date May 2015

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