NCT01247714

Clinical Evaluation of a Specific Enteral Diet for Diabetics

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Vegenat, S.A. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hyperglycemia
• Diabetics
• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	T-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_SUPPLEMENT	T-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_SUPPLEMENT	Glucerna	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_SUPPLEMENT	Novasource	Complete high protein diet for diabetic patients and hyperglycemic

Timeline

• Start date: 2009-09-01
• Primary completion: 2014-12-01
• Completion: 2015-05-01
• First posted: 2010-11-24
• Last updated: 2014-12-10

Locations

1 site across 1 country: Spain