Clinical Evaluation of a Normoproteic Diet

Study Overview
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Brief Summary
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The main objective of this trial is the clinical evaluation of a normoproteic diet, when this diet is used for total enteral nutrition in geriatric people. For 3 months,all the participants in the study will receive only tube feeding: The experimental group will receive the commercial preparation to evaluate (T-Diet Plus ®, Vegenat SA) and the control group will receive a standard diet (Jevity ®, Abbott Laboratories).

Detailed Description
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The project includes: Product tolerance study: gastrointestinal and metabolic complications related to the product administration. The monitoring of the intervention, and clinical and nutritional evaluation of the participants, including anthropometry, quality of life related to the health and clinical and nutritional status analytical evaluation (hematology and biochemistry). The determination of the major biochemical variables related to the lipid profile and assessment of the antioxidant defense system, and also certain markers of metabolic syndrome and associated cardiovascular risk.

Official Title
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Clinical Evaluation of a Normoproteic Diet With Ultra High Temperature Treatment

Conditions
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Severe Insufficient Nutrition

Intervention / Treatment
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* Dietary Supplement: T-Diet plus Standard
* Dietary Supplement: Jevity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 65 years old, of both sex, receiving total enteral nutrition by tube. Admitted to medically supervised institutions (homes, health centers). Requirement for total enteral nutrition standard, at least 3 months. Acceptance volunteer to participate in the study by signing the written informed consent (approved by the Ethics Committee of University Hospital Virgen de las Nieves). Exclusion Criteria: Patients who receive drugs with lipid composition. Unstable clinical situation. Patients with terminal illness. Refusal or physical or mental inability to cooperate in the study. Participating in another study. Other causes: social causes, humanitarian, non-cooperation, etc..

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>The group 1 will receive the experimental product T-Diet plus Standard for 3 months. | Dietary Supplement: T-Diet plus Standard<br>* T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition.<br>* Other names: TDP STD;|
| Active Comparator: Group 2<br>The group 2 will receive the control product Jevity (Abbott Laboratories) for 3 months. | Dietary Supplement: Jevity<br>* JEVITY is a diet for tube-fed patients in the medium to long term, to varying degrees of malnutrition with gastrointestinal disorders.<br>* Other names: JEV ABBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status evaluation | Clinical evaluation of a comercial product: T-Diet Plus (normoproteic and specific diet), when is used for total enteral nutrition in geriatric people. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific parameters measure | Confirm gastrointestinal and metabolic tolerance of the product. Consider the influence of the diet received on quality of life related to health. Study the changes in the nutritional status of elderly patients Assess changes in the lipid profile of patients Compare the evolution in blood levels of metabolic syndrome indicator parameters and other related to cardiovascular morbidity. Assess changes in the antioxidant defense system. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Enteral Nutrition, Severe insufficient nutrition, T-Diet plus Standard, Lipidic profile, Quality of life