Clinical Evaluation of a Specific Enteral Diet for Diabetics

Vegenat

Status: Unknown

Conditions: Hyperglycemia; Diabetics; Metabolic Syndrome

Treatments: Dietary Supplement: Glucerna; Dietary Supplement: T-Diet plus Diabet NP; Dietary Supplement: Novasource; Dietary Supplement: T-Diet plus Standard

Study type: Interventional

Funder types: Industry

Identifiers

NCT01247714

DIABET NP 2009-PROYECTO CDTI (Other Identifier)

VEGENAT-DIABET NP UGR

Details and patient eligibility

About

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).

Full 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).

Enrollment: 43 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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43 participants in 2 patient groups

Group 1

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: T-Diet plus Standard

Dietary Supplement: Novasource

Dietary Supplement: T-Diet plus Diabet NP

Dietary Supplement: Glucerna

Group 2

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: T-Diet plus Standard

Dietary Supplement: Novasource

Dietary Supplement: T-Diet plus Diabet NP

Dietary Supplement: Glucerna