Back to resultsNo-commercial Enteral Diet for Patients in Home Nutritional Therapy: Effects on Anthropometric and Biochemical Indices
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dietary therapy
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition
Eligibility Criteria
Inclusion Criteria:
- patients in home nutritional therapy receiving no-commercial enteral diets
Exclusion Criteria:
- baseline diseases others than neurological
Sites / Locations
- Federal University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dietary therapy Standardized diet
Dietary therapy Commercial diet group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Recovery of malnourished patients (weight, height, arm circumference)
weight, height, arm circumference
Secondary Outcome Measures
Full Information
NCT ID
NCT02314130
First Posted
March 18, 2013
Last Updated
December 10, 2014
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02314130
Brief Title
No-commercial Enteral Diet for Patients in Home Nutritional Therapy: Effects on Anthropometric and Biochemical Indices
Official Title
No-commercial Enteral Diet for Patients in Home Nutritional Therapy: Effects on Anthropometric and Biochemical Indices
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary therapy Standardized diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Dietary therapy Commercial diet group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recovery of malnourished patients (weight, height, arm circumference)
Description
weight, height, arm circumference
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients in home nutritional therapy receiving no-commercial enteral diets
Exclusion Criteria:
baseline diseases others than neurological
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania Morais, PhD
Organizational Affiliation
Federal of University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
19454554
Citation
Santos VF, Morais TB. Nutritional quality and osmolality of home-made enteral diets, and follow-up of growth of severely disabled children receiving home enteral nutrition therapy. J Trop Pediatr. 2010 Apr;56(2):127-8. doi: 10.1093/tropej/fmp033. Epub 2009 May 19.
Results Reference
background
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No-commercial Enteral Diet for Patients in Home Nutritional Therapy: Effects on Anthropometric and Biochemical Indices
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