Clinical Evaluation of a Specific Enteral Diet for Diabetics

Study Overview
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Brief Summary
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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
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This new complete diet has been carefully formulated, and incorporates functional ingredients based on: A good gastrointestinal and metabolic tolerance of the product. Beneficial outcomes in the nutritional status. 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).

Official Title
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Clinical Evaluation of a Specific Enteral Diet for Diabetics.A Randomised Cross-Over Study

Conditions
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Hyperglycemia, Diabetics, Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: T-Diet plus Standard
* Dietary Supplement: T-Diet plus Diabet NP
* Dietary Supplement: Glucerna
* Dietary Supplement: Novasource


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>The group 1 will receive the experimental product T-Diet plus Diabet NP for the first month followed by a reference diet corresponding to a current marketed product (Glucerna SR, Abbott) for the second month, then the patients will receive a control product non specific for diabetic patients (T-Diet plus Standard)for the third month, and finally a specific diet for diabetic patients (Novasource, Nestlé Healthcare Nutrition)for the fourth month. | Dietary Supplement: T-Diet plus Standard<br>* T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition.<br>* Other names: PLUS STD;Dietary Supplement: T-Diet plus Diabet NP<br>* T-Diet plus Diabet NP is a complete balanced oral nutrition supplement, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.<br>* Other names: DIABET NP;Dietary Supplement: Glucerna<br>* 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.<br>* Other names: GLCR;Dietary Supplement: Novasource<br>* Complete high protein diet for diabetic patients and hyperglycemic<br>* Other names: NVS;|
| Active Comparator: Group 2<br>The group 2 will receive a reference diet corresponding to a current marketed product (Glucerna SR, Abbott)for the first month, followed by the experimental product T-Diet plus Diabet NP for the second month, then the patients will receive a specific diet for diabetic patients (Novasource, Nestlé Healthcare Nutrition)for the third month, and finally a control product non specific for diabetic patients (T-Diet plus Standard)for the fourth month | Dietary Supplement: T-Diet plus Standard<br>* T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition.<br>* Other names: PLUS STD;Dietary Supplement: T-Diet plus Diabet NP<br>* T-Diet plus Diabet NP is a complete balanced oral nutrition supplement, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.<br>* Other names: DIABET NP;Dietary Supplement: Glucerna<br>* 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.<br>* Other names: GLCR;Dietary Supplement: Novasource<br>* Complete high protein diet for diabetic patients and hyperglycemic<br>* Other names: NVS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T-Diet plus Diabet NP, Diabetic, Enteral Nutrition, Glycaemic response, Metabolic Syndrome, Insulin resistance, Lipidic profile