Clinical Evaluation of a Normoproteic Diet

NCT01303289 | Completed

• 2 other identifiers: VEGENAT-TDP STD UGRTDP STANDARD 2006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Severe Insufficient Nutrition

Keywords

Total Enteral Nutrition; Severe insufficient nutrition; T-Diet plus Standard; Lipidic profile; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Specific parameters measure

  6 months

Study Arms (2)

Group 1

EXPERIMENTAL

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

Dietary Supplement: T-Diet plus Standard

Group 2

ACTIVE COMPARATOR

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

Dietary Supplement: Jevity

Interventions

T-Diet plus Standard DIETARY_SUPPLEMENT

T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition.

Also known as: TDP STD

Group 1

Jevity DIETARY_SUPPLEMENT

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

Also known as: JEV ABBT

Group 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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..

Sponsors & Collaborators

• Vegenat, S.A.: lead

Study Sites (1)

Department of Biochemistry and Molecular Biology II. University of Granada

Granada, Granada, 18100, Spain

Location

MeSH Terms

Interventions

Phentermine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Ángel Gil, PhD

  Departament of Biochemistry and Molecular Biology II. University of Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 24, 2011
• Study Start: February 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 24, 2011

Record last verified: 2011-02

Locations

ES (1)