Clinical Evaluation of a Specific Enteral Diet for Diabetics

Not Applicable

• Conditions: Hyperglycemia; Diabetics; Metabolic Syndrome
• Interventions: Dietary Supplement: T-Diet plus Standard; Dietary Supplement: T-Diet plus Diabet NP; Dietary Supplement: Glucerna; Dietary Supplement: Novasource

• Registration Number: NCT01247714
• Lead Sponsor: Vegenat, S.A.

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).

Study Timeline

• Study Start: 2009-09
• Status Verified: 2010-11
• Study First Submitted: 2010-11-23
• Study First Submitted QC: 2010-11-23
• Study First Posted: 2010-11-24
• Primary Completion: 2014-12
• Last Update Submitted: 2014-12-09
• Last Update Posted: 2014-12-10
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	T-Diet plus Diabet NP	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.
Group 1	Novasource	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.
Group 1	T-Diet plus Standard	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.
Group 2	Novasource	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
Group 1	Glucerna	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.
Group 2	T-Diet plus Standard	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
Group 2	T-Diet plus Diabet NP	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
Group 2	Glucerna	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Biochemistry and Molecular Biology II. University of Granada; 🇪🇸 Granada, Spain