Clinical Evaluation of a Specific Enteral Diet for Diabetics

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01247714
• Other study ID #: VEGENAT-DIABET NP UGR
• Secondary ID: DIABET NP 2009-P
• Status: Active, not recruiting
• Phase: N/A
• First received: November 23, 2010
• Last updated: December 9, 2014
• Start date: September 2009
• Est. completion date: May 2015

Study information

• Verified date: November 2010
• Source: Vegenat, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and ConsumptionSpain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: May 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetics
• Hyperglycemia
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

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.
• 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.
• 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.
• Novasource
Complete high protein diet for diabetic patients and hyperglycemic

Locations

Country	Name	City	State
Spain	Department of Biochemistry and Molecular Biology II. University of Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Vegenat, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No