Overview

This trial is active, not recruiting.

Conditions hyperglycemia, diabetics, metabolic syndrome
Treatments t-diet plus standard, t-diet plus diabet np, glucerna, novasource
Sponsor Vegenat, S.A.
Start date September 2009
End date December 2014
Trial size 43 participants
Trial identifier NCT01247714, DIABET NP 2009-PROYECTO CDTI, VEGENAT-DIABET NP UGR

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(Active Comparator)
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.
t-diet plus standard PLUS STD
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 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 GLCR
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 NVS
Complete high protein diet for diabetic patients and hyperglycemic
(Active Comparator)
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
t-diet plus standard PLUS STD
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 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 GLCR
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 NVS
Complete high protein diet for diabetic patients and hyperglycemic

Primary Outcomes

Measure
Nutritional status and Glycaemia
time frame: 9 months

Secondary Outcomes

Measure
Biochemicals parameters measure
time frame: 9 months

Eligibility Criteria

Male or female participants at least 55 years old.

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

Additional Information

Official title Clinical Evaluation of a Specific Enteral Diet for Diabetics.A Randomised Cross-Over Study
Principal investigator Ángel Gil, PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Vegenat, S.A..