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Clinical Trials/NCT01741870
NCT01741870
Completed
Not Applicable

The Effectiveness of a Need-based Nutritional Intervention Strategy to Improve the Nutritional Status of Elderly Nursing Home Residents

Asia University1 site in 1 country92 target enrollmentApril 2011
ConditionsMalnutrition

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malnutrition
Sponsor
Asia University
Enrollment
92
Locations
1
Primary Endpoint
Assessment of nutritional status with the Mini nutritional Assessment (MNA)
Status
Completed
Last Updated
last year

Overview

Brief Summary

To examine the effectiveness of a "need-based nutritional intervention" strategy in improving the nutritional and physical functional status of nursing home elderly.

Detailed Description

Ninety-two nursing home residents aged 65 years or older and BMI \<25 were randomly assigned to the intervention or control groups. Subjects in the treatment group received a soy-protein-based nutritional supplement, if his/her BMI was \<24kg/m2 and nutritional score was \<24 according to the Mini Nutritional Assessment. The supplementation would be suspended if both conditions were not met. At baseline and every 4 weeks up to 24 weeks, thereafter, all subjects were measured for anthropometric parameters. At baseline, 12 weeks and 24 weeks subjects were measured for blood biochemical indicators, handgrip strength and Barthel's index.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
December 2011
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ≥ 65 years of age
  • BMI ≤ 25 (kg/m2)
  • ≥1 month of residency
  • Able to self-feed or receive oral-feeding
  • Non-bed-ridden
  • Cognitively able to answer the questionnaire

Exclusion Criteria

  • 1.Hospitalized or having acute infection/diseases

Outcomes

Primary Outcomes

Assessment of nutritional status with the Mini nutritional Assessment (MNA)

Time Frame: Baseline and every 4 weeks, up to 24 weeks

Change from baseline in MNA score at 4, 8, 12, 16, 20 and 24 weeks

Secondary Outcomes

  • Biochemical indicators(Baseline, 12, and 24 weeks)

Study Sites (1)

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