A Need-based Nutritional Intervention in Nursing Home Residents

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741870
• Other study ID #: tsai1943
• Status: Completed
• Phase: N/A
• First received: November 29, 2012
• Last updated: December 3, 2012
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: Asia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. = 65 years of age

2. BMI = 25 (kg/m2)

3. =1 month of residency

4. Able to self-feed or receive oral-feeding

5. Non-bed-ridden

6. Cognitively able to answer the questionnaire

Exclusion Criteria:

1.Hospitalized or having acute infection/diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Nutritional supplement
Subjects will receive 50 g/day of a soy protein-based nutritional supplement containing 9.5 g protein, 250 kcal energy and all essential micronutrients

Locations

Country	Name	City	State
Taiwan	Asia University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Asia University

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Weatherall M. Protein-energy oral supplementation in malnourished nursing-home residents. Age Ageing. 2001 Jan;30(1):85. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical functional status	Change from baseline in Barthel's index and handgrip strength at 12 and 24 weeks	Baseline, 12 and 24 weeks	No
Other	Hospital admissions	Frequency of outpatient visits, emergency visits and hospital admission (length of stay) during the study	Baseline, and 24 weeks	No
Primary	Assessment of nutritional status with the Mini nutritional Assessment (MNA)	Change from baseline in MNA score at 4, 8, 12, 16, 20 and 24 weeks	Baseline and every 4 weeks, up to 24 weeks	No
Secondary	Biochemical indicators	Change from baseline in serum albumin and cholesterol concentrations, and hemoglobin, hematocrit and lymphocyte count status at 12, and 24 weeks.	Baseline, 12, and 24 weeks	No