Clinical Evaluation of a Specific Enteral Diet for Diabetics
Hyperglycemia, Diabetics, Metabolic Syndrome
About this trial
This is an interventional supportive care trial for Hyperglycemia focused on measuring T-Diet plus Diabet NP, Diabetic, Enteral Nutrition, Glycaemic response, Metabolic Syndrome, Insulin resistance, Lipidic profile
Eligibility Criteria
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
Sites / Locations
- Department of Biochemistry and Molecular Biology II. University of Granada
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Group 1
Group 2
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.
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