Clinical Evaluation of a Specific Enteral Diet for Diabetics
This trial is active, not recruiting.
|Conditions||hyperglycemia, diabetics, metabolic syndrome|
|Treatments||t-diet plus standard, t-diet plus diabet np, glucerna, novasource|
|Start date||September 2009|
|End date||December 2014|
|Trial size||43 participants|
|Trial identifier||NCT01247714, DIABET NP 2009-PROYECTO CDTI, VEGENAT-DIABET NP UGR|
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).
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||single blind (subject)|
|Primary purpose||supportive care|
Nutritional status and Glycaemia
time frame: 9 months
Biochemicals parameters measure
time frame: 9 months
Male or female participants at least 55 years old.
- 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.
- 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
|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).|
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