Clinical Evaluation of a Specific Enteral Diet for Diabetics.A Randomised Cross-Over Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperglycemia
- Sponsor
- Vegenat, S.A.
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Nutritional status and Glycaemia
- Last Updated
- 11 years ago
Overview
Brief 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).
Detailed 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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Nutritional status and Glycaemia
Time Frame: 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
Secondary Outcomes
- Biochemicals parameters measure(9 months)