Clinical Evaluation of a Specific Enteral Diet for Diabetics

Vegenat, S.A.43 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Hyperglycemia Diabetics Metabolic Syndrome

Interventions

T-Diet plus StandardDIETARY_SUPPLEMENT

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 NPDIETARY_SUPPLEMENT

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

GlucernaDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Biochemistry and Molecular Biology II. University of Granada

Granada, Granada, Spain

Outcomes

Primary Outcomes

Nutritional status and Glycaemia

* 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

Time frame: 9 months

Secondary Outcomes

Biochemicals parameters measure

* 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

Time frame: 9 months

Data from ClinicalTrials.gov

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