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Completed

NCT Number: NCT01303289

Clinical Evaluation of a Normoproteic Diet

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).

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biochemistry and Molecular Biology II. University of Granada

Granada, 18100, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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..

Treatment and study plan

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.

Other names: TDP STD

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.

Other names: JEV ABBT

Primary outcomes

  1. Nutritional status evaluation

    Time frame: 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 outcomes

  1. Specific parameters measure

    Time frame: 6 months

    • 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.

Sponsors and collaborators

Lead sponsor

Vegenat, S.A.

Industry

Registry information

Official study title

Clinical Evaluation of a Normoproteic Diet With Ultra High Temperature Treatment

Acronym: STDUGR

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 24, 2011
Registry last updated
Feb 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.