Clinical Evaluation of a Normoproteic Diet

Severe Insufficient Nutrition Clinical Trial

— STDUGR  

Official title:

Clinical Evaluation of a Normoproteic Diet With Ultra High Temperature Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303289
• Other study ID #: VEGENAT-TDP STD UGR
• Secondary ID: TDP STANDARD 200
• Status: Completed
• Phase: N/A
• First received: February 17, 2011
• Last updated: February 22, 2011
• Start date: February 2006
• Est. completion date: December 2007

Study information

• Verified date: February 2011
• Source: Vegenat, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and ConsumptionSpain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Severe Insufficient Nutrition

Intervention

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.
• Jevity
JEVITY is a diet for tube-fed patients in the medium to long term, to varying degrees of malnutrition with gastrointestinal disorders.

Locations

Country	Name	City	State
Spain	Department of Biochemistry and Molecular Biology II. University of Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Vegenat, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No