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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314130
• Other study ID #: 1732/08
• Status: Completed
• Phase: N/A
• First received: March 18, 2013
• Last updated: December 10, 2014
• Start date: May 2009
• Est. completion date: April 2011

Study information

• Verified date: March 2013
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• baseline diseases others than neurological

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition

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.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of malnourished patients (weight, height, arm circumference)	weight, height, arm circumference	Two years	No