Clinical Evaluation of a Normoproteic Diet (STDUGR)

Vegenat

Status: Completed

Conditions: Severe Insufficient Nutrition

Treatments: Dietary Supplement: Jevity; Dietary Supplement: T-Diet plus Standard

Study type: Interventional

Funder types: Industry

Identifiers

NCT01303289

TDP STANDARD 2006 (Other Identifier)

VEGENAT-TDP STD UGR

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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..

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Group 1

Experimental group

Description:

The group 1 will receive the experimental product T-Diet plus Standard for 3 months.

Treatment:

Dietary Supplement: T-Diet plus Standard

Group 2

Active Comparator group

Description:

The group 2 will receive the control product Jevity (Abbott Laboratories) for 3 months.

Treatment:

Dietary Supplement: Jevity