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No-commercial Enteral Diet for Patients in Home Nutritional Therapy: Effects on Anthropometric and Biochemical Indices

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ClinicalTrials.gov Identifier: NCT02314130
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
Tania Morais, Federal University of São Paulo

Brief Summary:
The objective is to evaluate the effect of no-commercial enteral diet for patients in home nutritional therapy in anthropometric and biochemical indices comparing to patients using commercial enteral diets.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: Dietary therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: No-commercial Enteral Diet for Patients in Home Nutritional Therapy: Effects on Anthropometric and Biochemical Indices
Study Start Date : May 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dietary therapy Standardized diet
The study was constituted by sixty-six patients, thirty-three in each group. Patients on not industrialized enteral diet (standardized diet group) entered at random in the study and were matched by gender, age, socioeconomic status and medical diagnosis to patients using commercial diet (commercial group). The evaluation consisted of anthropometric measures of weight, height, arm circumference, triceps skin fold and biochemical índices at baseline and at the end of the intervention.
Dietary Supplement: Dietary therapy
A enteral diet formulation was developed to meet dietary requirements of adult patients. The formulation was standarized in household measures so that caregivers would prepare it and delivered it at the patients' home. Anthropometric measurements and blood samples were taken at baseline and at the end of the intervention which lasted four months.

No Intervention: Dietary therapy Commercial diet group
The study was constituted by sixty-six patients, thirty-three in each group. Patients on not industrialized enteral diet (standardized diet group) entered at random in the study and were matched by gender, age, socioeconomic status and medical diagnosis to patients using commercial diet (commercial group). The evaluation consisted of anthropometric measures of weight, height, arm circumference, triceps skin fold and biochemical índices at baseline and at the end of the intervention.



Primary Outcome Measures :
  1. Recovery of malnourished patients (weight, height, arm circumference) [ Time Frame: Two years ]
    weight, height, arm circumference



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients in home nutritional therapy receiving no-commercial enteral diets

Exclusion Criteria:

  • baseline diseases others than neurological

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314130


Locations
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Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Tania Morais, PhD Federal of University of Sao Paulo

Publications:
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Responsible Party: Tania Morais, PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02314130     History of Changes
Other Study ID Numbers: 1732/08
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: March 2013

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders