Diabetics, Hyperglycemia, Metabolic Syndrome
Conditions
Keywords
T-Diet plus Diabet NP, Diabetic, Enteral Nutrition, Glycaemic response, Metabolic Syndrome, Insulin resistance, Lipidic profile
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).
Interventions
DIETARY_SUPPLEMENTT-Diet plus Standard
T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition.
DIETARY_SUPPLEMENTT-Diet plus Diabet NP
T-Diet plus Diabet NP is a complete balanced oral nutrition supplement, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
DIETARY_SUPPLEMENTGlucerna
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.
DIETARY_SUPPLEMENTNovasource
Complete high protein diet for diabetic patients and hyperglycemic
Sponsors
Vegenat, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status and Glycaemia | 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
| Measure | Time frame | Description |
|---|---|---|
| Biochemicals parameters measure | 9 months | * 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 |
Countries
Spain
Outcome results
None listed