Clinical Evaluation of a Normoproteic Diet

Not Applicable

Completed

• Conditions: Severe Insufficient Nutrition
• Interventions: Dietary Supplement: T-Diet plus Standard; Dietary Supplement: Jevity

• Registration Number: NCT01303289
• Lead Sponsor: Vegenat, S.A.

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2007-01
• Study Completion: 2007-12
• Status Verified: 2011-02
• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-22
• Last Update Submitted: 2011-02-22
• Study First Posted: 2011-02-24
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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..

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	T-Diet plus Standard	The group 1 will receive the experimental product T-Diet plus Standard for 3 months.
Group 2	Jevity	The group 2 will receive the control product Jevity (Abbott Laboratories) for 3 months.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Specific parameters measure	6 months	1. Confirm gastrointestinal and metabolic tolerance of the product.; 2. Consider the influence of the diet received on quality of life related to health.; 3. Study the changes in the nutritional status of elderly patients; 4. Assess changes in the lipid profile of patients; 5. Compare the evolution in blood levels of metabolic syndrome indicator parameters and other related to cardiovascular morbidity.; 6. Assess changes in the antioxidant defense system.

Trial Locations

Locations (1)

Department of Biochemistry and Molecular Biology II. University of Granada; 🇪🇸 Granada, Spain