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

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Dietary therapy

• Registration Number: NCT02314130
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2013-03
• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2014-12-10
• Last Update Submitted: 2014-12-10
• Study First Posted: 2014-12-11
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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

Exclusion Criteria

• baseline diseases others than neurological

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary therapy Standardized diet	Dietary therapy	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

Name	Time	Method
Recovery of malnourished patients (weight, height, arm circumference)	Two years	weight, height, arm circumference

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil