Clinical Evaluation of a Normoproteic Diet (STDUGR)

Clinical Evaluation of a Normoproteic Diet With Ultra High Temperature Treatment

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).

Study Overview

• Status: Completed
• Conditions: Severe Insufficient Nutrition
• Intervention / Treatment: Dietary supplement: T-Diet plus Standard; Dietary supplement: Jevity

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18100
    • Department of Biochemistry and Molecular Biology II. University of Granada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vegenat, S.A.
• Investigators: Principal Investigator: Ángel Gil, PhD, Departament of Biochemistry and Molecular Biology II. University of Granada

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: February 17, 2011
• First Submitted That Met QC Criteria: February 22, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): February 24, 2011
• Last Update Submitted That Met QC Criteria: February 22, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Quality of life; Total Enteral Nutrition; Severe insufficient nutrition; T-Diet plus Standard; Lipidic profile
• Other Study ID Numbers: VEGENAT-TDP STD UGR; TDP STANDARD 2006 (Other Identifier: VEGENAT, S.A.)